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FDA 510(k) Application Details - K130164
Device Classification Name
Powered Laser Surgical Instrument
More FDA Info for this Device
510(K) Number
K130164
Device Name
Powered Laser Surgical Instrument
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
878.4810
More FDA Info for this Regulation Number
Classification Product Code
GEX
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More FDA Info for this Product Code
Date Received
01/23/2013
Decision Date
03/24/2013
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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