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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 pelvic organ prolapse, transvaginally placed
510(k) Number K063562
Device Name GYNECARE PROSIMA PELVIC FLOOR REPAIR SYSTEMS
Applicant
ETHICON, INC.
P.O. BOX 151
ROUTE 22 WEST
SOMERVILLE,  NJ  08876
Applicant Contact PATRICE NAGODA
Correspondent
ETHICON, INC.
P.O. BOX 151
ROUTE 22 WEST
SOMERVILLE,  NJ  08876
Correspondent Contact PATRICE NAGODA
Regulation Number884.5980
Classification Product Code
OTP  
Date Received11/27/2006
Decision Date 02/26/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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