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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed
510(k) Number K013718
Device Name GYNEMESH PROLENE SOFT (POLYPROPYLENE) NONABSORBABLE SYNTHETIC SURGICAL MESH FOR PELVIC FLOOR REPAIR
Applicant
Gynecare, A Div. of Ethicon, Inc.
P.O. Box 151
Somerville,  NJ  08876
Applicant Contact GREGORY R JONES
Correspondent
Gynecare, A Div. of Ethicon, Inc.
P.O. Box 151
Somerville,  NJ  08876
Correspondent Contact GREGORY R JONES
Regulation Number878.3300
Classification Product Code
OTO  
Date Received11/08/2001
Decision Date 01/08/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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