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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 K992901
Device Name GYNECARE VERSAPOINT G-VAP ELECTRODE
Applicant
Gynecare, Inc.
P.O. Box 151
Somerville,  NJ  08876
Applicant Contact GREGORY JONES
Correspondent
Gynecare, Inc.
P.O. Box 151
Somerville,  NJ  08876
Correspondent Contact GREGORY JONES
Regulation Number884.1690
Classification Product Code
HIH  
Subsequent Product Code
KNF  
Date Received08/30/1999
Decision Date 01/18/2000
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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