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FDA 510(k) Application Details - K111831
Device Classification Name
Powered Laser Surgical Instrument With Microbeam\Fractional Output
More FDA Info for this Device
510(K) Number
K111831
Device Name
Powered Laser Surgical Instrument With Microbeam\Fractional Output
Applicant
BIO-MED U.S.A., INC.
111 ELLISON ST.
PATERSON, NJ 07505 US
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YOUNG CHI
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Regulation Number
878.4810
More FDA Info for this Regulation Number
Classification Product Code
ONG
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/28/2011
Decision Date
12/19/2011
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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