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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fixation, Non-Absorbable Or Absorbable, For Pelvic Use
510(k) Number K042603
Device Name GYNECARE PROLENE FASTENER SYSTEM
Applicant
Ethicon, Inc.
P.O Box 151, Route 22 W.
Somerville,  NJ  08876
Applicant Contact SEAN O'BRYAN
Correspondent
Ethicon, Inc.
P.O Box 151, Route 22 W.
Somerville,  NJ  08876
Correspondent Contact SEAN O'BRYAN
Regulation Number884.4530
Classification Product Code
PBQ  
Date Received09/24/2004
Decision Date 12/22/2004
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
Predetermined Change
Control Plan Authorized		 No
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