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FDA 510(k) Application Details - K131805
Device Classification Name
Powered Laser Surgical Instrument
More FDA Info for this Device
510(K) Number
K131805
Device Name
Powered Laser Surgical Instrument
Applicant
INCISIVE INC.
26 REBECCA CT
HOMOSASSA, FL 34446 US
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Contact
KATHY MAYNOR
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
06/19/2013
Decision Date
07/18/2013
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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