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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, Gynecologic (And Accessories)
510(k) Number K131656
Device Name MORCELLEX SIGMA GENERATOR
Applicant
ETHICON, INC.
P.O. BOX 151
ROUTE 22 WEST
SOMERVILLE,  NJ  08876 -0151
Applicant Contact SARAH MCMANUS
Correspondent
ETHICON, INC.
P.O. BOX 151
ROUTE 22 WEST
SOMERVILLE,  NJ  08876 -0151
Correspondent Contact SARAH MCMANUS
Regulation Number884.1720
Classification Product Code
HET  
Date Received06/06/2013
Decision Date 09/27/2013
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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