FDA 510(k) Application Details - K133272

Device Classification Name Laparoscope, General & Plastic Surgery

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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
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Regulation Number 876.1500

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Classification Product Code GCJ
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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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