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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 K100280
Device Name GYNCARE MORCELLEX TISSUE MORCELLATOR
Applicant
Ethicon, Inc.
Route 22 W.
Somerville,  NJ  08876 -0151
Applicant Contact BRYAN LISA
Correspondent
Ethicon, Inc.
Route 22 W.
Somerville,  NJ  08876 -0151
Correspondent Contact BRYAN LISA
Regulation Number884.1720
Classification Product Code
HET  
Date Received02/01/2010
Decision Date 03/24/2010
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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