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FDA 510(k) Application Details - K131955
Device Classification Name
Powered Laser Surgical Instrument
More FDA Info for this Device
510(K) Number
K131955
Device Name
Powered Laser Surgical Instrument
Applicant
MONTERIS MEDICAL, INC.
1193 SHERMAN ST
ALAMEDA, CA 94501 US
Other 510(k) Applications for this Company
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CRAIG COOMBS
Other 510(k) Applications for this Contact
Regulation Number
878.4810
More FDA Info for this Regulation Number
Classification Product Code
GEX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/27/2013
Decision Date
07/30/2013
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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