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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 K133272
Device Name VERSACUT + TISSUE MORCELLATOR
Applicant
LUMENIS LTD.
31 HAAVODA ST.
BINYAMINA,  IL 30500
Applicant Contact YORAM LEVY
Correspondent
LUMENIS LTD.
31 HAAVODA ST.
BINYAMINA,  IL 30500
Correspondent Contact YORAM LEVY
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received10/24/2013
Decision Date 05/13/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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