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FDA 510(k) Application Details - K162762
Device Classification Name
Powered Laser Surgical Instrument
More FDA Info for this Device
510(K) Number
K162762
Device Name
Powered Laser Surgical Instrument
Applicant
Monteris Medical, Inc.
14755 27th Avenue North; Suite C
Plymouth, MN 55447 US
Other 510(k) Applications for this Company
Contact
David H. Mueller
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
09/30/2016
Decision Date
10/26/2016
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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