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FDA 510(k) Application Details - K140388
Device Classification Name
Powered Laser Surgical Instrument
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510(K) Number
K140388
Device Name
Powered Laser Surgical Instrument
Applicant
LUMENIS LTD.
155 BIALIK STREET
RAMAT GAN 5252346 IL
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MERAV YARMUS
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Regulation Number
878.4810
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Classification Product Code
GEX
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More FDA Info for this Product Code
Date Received
02/14/2014
Decision Date
03/14/2014
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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