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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 K061050
Device Name GYNECARE MORCELLEX TISSUE MORCELLATOR, MODELS MX0100 AND MX0100R
Applicant
ETHICON, INC.
P.O. BOX 151
ROUTE 22 WEST
SOMERVILLE,  NJ  08876
Applicant Contact BRYAN LISA
Correspondent
ETHICON, INC.
P.O. BOX 151
ROUTE 22 WEST
SOMERVILLE,  NJ  08876
Correspondent Contact BRYAN LISA
Regulation Number884.1720
Classification Product Code
HET  
Date Received04/17/2006
Decision Date 07/14/2006
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
Recalls CDRH Recalls
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