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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name hysteroscope (and accessories)
510(k) Number K040302
Device Name VERSAPOINT RESECTOSCOPIC SYSTEM
Applicant
GYNECARE, A DIV. OF ETHICON, INC.
U.S. ROUTE 22 WEST
P.O.BOX 151
SOMERVILLE,  NJ  08876
Applicant Contact PATRICIA M HOJNOSKI
Correspondent
GYNECARE, A DIV. OF ETHICON, INC.
U.S. ROUTE 22 WEST
P.O.BOX 151
SOMERVILLE,  NJ  08876
Correspondent Contact PATRICIA M HOJNOSKI
Regulation Number884.1690
Classification Product Code
HIH  
Subsequent Product Code
HFI  
Date Received02/09/2004
Decision Date 03/09/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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