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FDA 510(k) Application Details - K133272
Device Classification Name
Laparoscope, General & Plastic Surgery
More FDA Info for this Device
510(K) Number
K133272
Device Name
Laparoscope, General & Plastic Surgery
Applicant
LUMENIS LTD.
31 HAAVODA ST.
BINYAMINA 30500 IL
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Contact
YORAM LEVY
Other 510(k) Applications for this Contact
Regulation Number
876.1500
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Classification Product Code
GCJ
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More FDA Info for this Product Code
Date Received
10/24/2013
Decision Date
05/13/2014
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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