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FDA 510(k) Application Details - K061966
Device Classification Name
Powered Laser Surgical Instrument
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510(K) Number
K061966
Device Name
Powered Laser Surgical Instrument
Applicant
LIGHT INSTRUMENT 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
GEX
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More FDA Info for this Product Code
Date Received
07/12/2006
Decision Date
09/27/2006
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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