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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, General & Plastic Surgery
510(k) Number K050639
Device Name LUMENIS VERSACUT TISSUE MORCELLATOR SYSTEM
Applicant
Lumenis, Inc.
2400 Condensa St.
Santa Clara,  CA  95051 -0901
Applicant Contact MARTHA MURARI
Correspondent
Lumenis, Inc.
2400 Condensa St.
Santa Clara,  CA  95051 -0901
Correspondent Contact MARTHA MURARI
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received03/14/2005
Decision Date 03/31/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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