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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 K994418
Device Name VERSAPOINT ELECTROSURGERY SYSTEM (SCUBA)
Applicant
ETHICON, INC.
ROUTE 22 WEST
P.O. BOX 151
SOMERVILLE,  NJ  08876 -0151
Applicant Contact GREGORY JONES
Correspondent
ETHICON, INC.
ROUTE 22 WEST
P.O. BOX 151
SOMERVILLE,  NJ  08876 -0151
Correspondent Contact GREGORY JONES
Regulation Number884.1690
Classification Product Code
HIH  
Subsequent Product Code
KNF  
Date Received12/29/1999
Decision Date 01/24/2000
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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