Search Results for ''

published presentations and documents on DocSlides.

Section 5510K Summary A 0 As required by 21 CFR 80792Polyuretha

Section 5510K Summary A 0 As required by 21 CFR 80792Polyuretha

by freya

Classification Name: Colonoscope/Sigmoidoscope Acc...

x0000x0000D2 xMCIxD 0 xMCIxD 0 As with the predicate device the Ca

x0000x0000D2 xMCIxD 0 xMCIxD 0 As with the predicate device the Ca

by cadie

Statement of Intended Use The Cayacontoured diaphr...

C5*+$"T,'"$4,+IT:6I2,+0*C,5".+S,H($IJ,T*0,VI,:+I.,'"$4,4*6.,*0.,+(#$,T

by hailey

a*$I6"*5+,/+I.J !"#$%&'()*+&,-. /+)"#0%11&/+%%0 20...

This summary of 510(k) safety and effectiveness information is being s

This summary of 510(k) safety and effectiveness information is being s

by jaena

Exhibit#1 JUN 6 62012 51000 SUMMARY accordance wit...

3DJHRIPSCPublishingServices(301)443-6740

3DJHRIPSCPublishingServices(301)443-6740

by byrne

FORMFDA3881(7/17) F '(3$570(172)+($/7+$1&#x...

DEPARTMENT OF HEALTH HUMAN SERVICES Public Health ServiceFood and Dr

DEPARTMENT OF HEALTH HUMAN SERVICES Public Health ServiceFood and Dr

by vivian

Page 2-This letter will allow you to begin marketi...

DEPARTMENT OF HEALTH HUMIAN SERVICESFood uricd Drugo Adiuiinsnffaiion

DEPARTMENT OF HEALTH HUMIAN SERVICESFood uricd Drugo Adiuiinsnffaiion

by garcia

Page 2 -Mr. ZhaoPlease be advised that FDA's issua...

SERJCESDEPARTMENT OF HEALTH HUMAN SERVICES Public Health Servi

SERJCESDEPARTMENT OF HEALTH HUMAN SERVICES Public Health Servi

by bety

Page 2 -Mr. ZhaoPlease be advised that FDA's issua...

MediSURG Ltd100 West Fornance StreetNorristown PA 19401Phone 610 2

MediSURG Ltd100 West Fornance StreetNorristown PA 19401Phone 610 2

by isabella

identically when placed in contact with tissue sin...

DEPARTMENT OF HEALTH HUMAN SERVICES IPublic Health ServiceFood and D

DEPARTMENT OF HEALTH HUMAN SERVICES IPublic Health ServiceFood and D

by singh

Page 2- Dr. GerkensmneierPlease be advised that FD...

by ashley

U.S. Food & Drug 10903 New Hampshire Avenue Doc ID...

by cady

USFoodDrug10903 NewHampshireAvenueDoc ID 040170420...

by winnie

U.S. Food & Drug 10903 New Hampshire Avenue 3 Silv...

MAY 2 ZOPI510k Summary of Safety and Effectiveness for theProtectiSco

MAY 2 ZOPI510k Summary of Safety and Effectiveness for theProtectiSco

by lam

/ko S/vZ7LThe ProtectiScope CS Non-intrapull colon...

by reagan

U.S. Food & Drug 10903 New Hampshire Avenue Doc ID...

JUti 14 2004510k Safety SummaryA Name of Device Trade Name Stellartech

JUti 14 2004510k Safety SummaryA Name of Device Trade Name Stellartech

by wang

LI T E Technical characteristicsThe technological ...

Home Inspections Compliance Enforcement and Criminal Investigations

Home Inspections Compliance Enforcement and Criminal Investigations

by helene

Mibo Medical Group 11/20/18 Office of Medica...

by mila-milly

nics NIRA Traditional 510(k) Premarket Notificati...

by ivy

U.S. Food & Drug 10903 New Hampshire Avenue Doc ID...

by madeline

U.S. Food & Drug 10903 New Hampshire Avenue Doc ID...

CONFIDENTIAL Maynrot bereproduced withoutfwritten permission fromEdwa

CONFIDENTIAL Maynrot bereproduced withoutfwritten permission fromEdwa

by clara

CONFIDENTIALFEE r ,(~si [~ s ~ic []j(,~ c s May no...

by oryan

U.S. Food & Drug 10903 New Hampshire Avenue Doc ID...

510k SUMMARY MR320DENTSPLY InternationalSusquehanna Commerce Center

510k SUMMARY MR320DENTSPLY InternationalSusquehanna Commerce Center

by gelbero

DEPARTMENT OF HEALTH & HUMAN SERVICES Public Healt...

510K SUMMARYAPR 7 2004 c ooS VIThis summary of 510Ok safety

510K SUMMARYAPR 7 2004 c ooS VIThis summary of 510Ok safety

by olivia

7. Performance In terms of Physical specification,...

c L ILo3SEP 2 2004CADENCE 510k SUBMISSION Cadence Fetal MonitorEdan I

c L ILo3SEP 2 2004CADENCE 510k SUBMISSION Cadence Fetal MonitorEdan I

by phoebe

2 DeviceProprietary Name Cadence Ante parturn Feta...

September 4 2020

September 4 2020

by cecilia

MEBO Life Science Inc. ℅ Wei - Regulatory manage...

Section 5 510k Summary

Section 5 510k Summary

by amey

5 - 2 C Predicate Device Comparis on : Lepu Medic...

by skylar

Page Ilof 3 MAR I0 7-Feb-IlI Joan E. Spiegel, M.D....

by teresa

Section 5 Page 2 of 7 Number : 21 CFR 878.44...

by badra

U.S. Food & Drug 10903 New Hampshire Avenue Doc ID...

KotU TAugust 3 2008Page 128Attachment 8510k SummaryFEG Textiltechn

KotU TAugust 3 2008Page 128Attachment 8510k SummaryFEG Textiltechn

by taylor

August 3, 2008et+Page 129Establishment Registratio...

Integrated Innovo -s5i system option -510k) Preniorket Notification
..

Integrated Innovo -s5i system option -510k) Preniorket Notification ..

by thomas

JUL 2 6 2011 510(k) Summary In accordance with 21 ...

by oconnor

U.S. Food & Drug 10903 New Hampshire Avenue Doc ID...

Section C 510(k) Summary

Section C 510(k) Summary

by morgan

FES 4 2014 510(K) Summary "This summary of 510(k) ...

Assistive Technology AT

Assistive Technology AT

by natalia-silvester

services provided through . Oklahoma ABLE Tech, a...

AT services provided through

AT services provided through

by tatiana-dople

Oklahoma ABLE Tech, a contractor for the . Oklaho...

SFood DrugAdministration10903 NewHampshireAvenue Doc ID 0401704

SFood DrugAdministration10903 NewHampshireAvenue Doc ID 0401704

by byrne

e: K193446 Trade/Device Name:Bare: 808Regulation ...

510k Summary1 Product name and descriptiona Scientific name Phaen

510k Summary1 Product name and descriptiona Scientific name Phaen

by caitlin

5. Discussion of Legally Marketed Device, includin...

by jordyn

U.S. Food & Drug 10903 New Hampshire Avenue Doc ID...

TABLE OF CONTENTS

TABLE OF CONTENTS

by tracy

I. INTRODUCTION .....................................