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Premarket published presentations and documents on DocSlides.

BURREN SPRINGS TRIMT SuperCitriMax 75 DAY PREMARKET NOTIFICATION SECTION
BURREN SPRINGS TRIMT SuperCitriMax 75 DAY PREMARKET NOTIFICATION SECTION
by olivia-moreira
HISTORY 4F USE I SAFETY EVIDENCE THE LONG TERM HI...
Guidance for Industry Applications for Premarket Review of New Tobacco Products DRAFT GUIDANCE This guidance docume t is being d stributed f r comment purposes only
Guidance for Industry Applications for Premarket Review of New Tobacco Products DRAFT GUIDANCE This guidance docume t is being d stributed f r comment purposes only
by myesha-ticknor
Com ents and suggestio ns regar ing this draft do...
Benefit Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications k with Different Technological Characteristics Draft Guidance for Industry and Food and Drug Admin
Benefit Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications k with Different Technological Characteristics Draft Guidance for Industry and Food and Drug Admin
by tatiana-dople
Document issued on July 15 2014 You should submit...
Convenience Kits Interim Regulatory Guidance This document is intended to provide guidance regarding a new premarket notification regulatory strategy for convenience kits
Convenience Kits Interim Regulatory Guidance This document is intended to provide guidance regarding a new premarket notification regulatory strategy for convenience kits
by natalia-silvester
It does not create or confer any rights for or on...
K Page I of k Premarket Notification CONCEIVE PLUS K
K Page I of k Premarket Notification CONCEIVE PLUS K
by calandra-battersby
155 North Wacker Drive Chicago IL 60606 CONTCTPES...
K tS Siemens syngovia IVI Workflows k Premarket Notifi
K tS Siemens syngovia IVI Workflows k Premarket Notifi
by liane-varnes
87h JAN 22 213 Identification of the Submitter Sub...
Intent to Exempt Certain Class II and Class I Reserved medical devices from premarket requirements
Intent to Exempt Certain Class II and Class I Reserved medical devices from premarket requirements
by kittie-lecroy
Document issued on August 1 2014 You should sub...
Contains Nonbinding Recommendations
Contains Nonbinding Recommendations
by myesha-ticknor
1 Premarket Notification Requirements Concerning ...
Siemens syngo.PET&CT Oncology Strictly Confidential510(O) Premarket No
Siemens syngo.PET&CT Oncology Strictly Confidential510(O) Premarket No
by giovanna-bartolotta
Siemens syngo.PEr&cT Oncology Stricly Confidential...
Global Regulatory Affairs
Global Regulatory Affairs
by min-jolicoeur
US . vs. EU. Nariko Koto, MBA. Global Regulatory/...
Contains Nonbinding Recommendations
Contains Nonbinding Recommendations
by min-jolicoeur
1 Premarket Notification Requirements Concerning ...
device-related adverse events) (21 CFR 803); good manufacturing practi
device-related adverse events) (21 CFR 803); good manufacturing practi
by yoshiko-marsland
Misbranding by reference to premarket notification...
1 © EAS Consulting Group, LLC
1 © EAS Consulting Group, LLC
by luanne-stotts
. Les Weinstein. FDA’s Center for Tobacco Prod...
Compounded Drugs and Lack of Premarket FDA-Approval
Compounded Drugs and Lack of Premarket FDA-Approval
by calandra-battersby
Compounded Drugs and Lack of Premarket FDA-Approv...
Summary of SUBMITTER'S NAME: Entific Medical Systems Box 16024 PERSON:
Summary of SUBMITTER'S NAME: Entific Medical Systems Box 16024 PERSON:
by sandsomber
Technological characteristics, Comparison table Ma...
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...
Dermal Photo
Dermal Photo
by mila-milly
nics NIRA Traditional 510(k) Premarket Notificati...
SEP tO 2 004 K o LqSECTION 16 510K SUMMARY1 DATE PREPAREDJune
SEP tO 2 004 K o LqSECTION 16 510K SUMMARY1 DATE PREPAREDJune
by davis
diastolic blood pressure, and pulse rate (heart ra...
V rcuje iz510k Summary of Safety and EffectivenessApplicant Name
V rcuje iz510k Summary of Safety and EffectivenessApplicant Name
by joanne
Collagen Matrix, Inc.510(k) Summary of Safety and ...
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 ...
The FDA Approval Process for
The FDA Approval Process for
by unita
New Devices. Roxana Mehran, MD, MSCAI, FACC, FAHA,...
Medical Device Cybersecurity: FDA Perspective
Medical Device Cybersecurity: FDA Perspective
by delcy
Suzanne B. Schwartz, MD, MBA. Associate Director f...