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FDA 510(k) Application Details - K031425
Device Classification Name
Powered Laser Surgical Instrument
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510(K) Number
K031425
Device Name
Powered Laser Surgical Instrument
Applicant
LIGHT BIOSCIENCE, LLC
5818 PRIONCESS CAROLINE PLACE
LEESBURG, FL 34748 US
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Contact
ROBERT T HANDREN, JR.
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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
05/05/2003
Decision Date
12/15/2004
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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