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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name coagulator-cutter, endoscopic, bipolar (and accessories)
510(k) Number K111751
Device Name VERSAPOINT II BIPOLAR ELECTROSURGERY GENERATOR, VERSAPOINT II 44MM ANGLED LOOP ELECTRODE, VERSAPOINT II FOOTSWITCH, VERS
Applicant
ETHICON, INC.
ROUTE 22 WEST
SOMERVILLE,  NJ  08876 -0151
Applicant Contact BRIAN A KANERVIKO
Correspondent
ETHICON, INC.
ROUTE 22 WEST
SOMERVILLE,  NJ  08876 -0151
Correspondent Contact BRIAN A KANERVIKO
Regulation Number884.4150
Classification Product Code
HIN  
Subsequent Product Code
HIH  
Date Received06/22/2011
Decision Date 12/02/2011
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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