PDF-Comparison to Predicate Device

VI The Codman Bipolar Cord and Tubing Setis substantially equivalent to the predicate device and eligible for the Special 510k process asthe proposeddevice has the following similarities to the predic. Carpal Tunnel Therapy. Team Therapy: Adam . Gohl. and John Peponis, BME Undergraduates. Advisor: Dr. Eric Meyer. Tech Advisor: Dr. Gerald . LeCarpentier. Background. Background. Percentage of Employed Adults* Aged 18–64 Years Who Had Carpal Tunnel Syndrome† in the Past 12 Months, by Sex and Age Group — National Health Interview Survey, 2010. Exhibit#1 JUN 6 62012 51000 SUMMARY accordance with the requirements of SMDA 1990 and 21 CFR Section 5 Page 2 of 7 Number : 21 CFR 878.4400 Product Co de: GEI Device Class: Class II Classification Panel: General & Plastic Surgery 5. Legally Marketed Predicate Device(s) Manufacturer Page Ilof 3 MAR I0 7-Feb-IlI Joan E. Spiegel, M.D. 10 Coleman Ct. Tel -617-935-3500 Natick, MA 01760 Official Contact: Joan Spiegel, M.D. Proprietary or Trade Name: Easy Cuffrm Common/Usual Name: Cuff U.S. Food & Drug 10903 New Hampshire Avenue Doc ID# 04017.04.16 Silver Spring, MD 20993 www.fda.gov June 16, 2020 Koya, Inc. ℅ Robert Packard President Medical Device Academy, Inc. 345 Lincoln Hill identically when placed in contact with tissue since they are the sameelectronic system.PPage 33 of 101 DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health ServiceFood and Drug Administration9200 Corp 72655 The ABPI is indicated for use on adult subjects at risk of having or developing arterial disease (PAD). The ABPI MD is intended for the rapid measurement of (PVR)/volume plethysmograd MEBO Life Science Inc. ℅ Wei - Regulatory manager Vee Care (Asia) Limited 17th Chung Pont Commercial Building, 300 Hennessy Road Hong Kong, CHN Hong Kong Re: K193439 Trade/Device Name: MEBO Wound Statement of Intended Use The Cayacontoured diaphragm is indicated for the prevention of pregnancy in women who elect to use diaphragms as a method of contraception It is recommended for use with a co Page Ilof 3 MAR I07-Feb-IlIJoan E Spiegel MD10 Coleman Ct Tel -617-935-3500Natick MA 01760Official Contact Joan Spiegel MDProprietary or Trade Name Easy CuffrmCommon/Usual Name Cuff tracheal tube infl USFoodDrug10903 NewHampshireAvenueDoc ID 040170416SilverSpringMD20993wwwfdagovJune 23 2020BEGO Bremer Goldschlgerei Wilh Herbst GmbH Co KG PriPOul BomMost Responsible PersonRegulatory Technology Serv INVIVO CORPORATION 510K NOTIFICATION3160 MRI PATIENT MONITORING SYSTEMA combination of wireless communication radio frequency RF shielding digital signalprocessing DSP and adaptable mounting technolog U.S. Food & Drug 10903 New Hampshire Avenue Doc ID# 04017.04.1 5 Silver Spring, MD 20993 www.fda.gov May 21, 2020 CooperSurgical, Inc. Kyle Hooper Regulatory Affairs Associate 95 Corporate Drive Trumb Page 2 of 5 A test line of color intensity greater than or equal to the comparator line indicates diminished ovarian reserve. I. Substa ntial Equivalence Information: 1. Predicate d e vice name(s)