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FDA 510(k) Application Details - K130028
Device Classification Name
Powered Laser Surgical Instrument With Microbeam\Fractional Output
More FDA Info for this Device
510(K) Number
K130028
Device Name
Powered Laser Surgical Instrument With Microbeam\Fractional Output
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
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Classification Product Code
ONG
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/03/2013
Decision Date
09/03/2013
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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