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FDA 510(k) Application Details - K083082
Device Classification Name
Powered Laser Surgical Instrument
More FDA Info for this Device
510(K) Number
K083082
Device Name
Powered Laser Surgical Instrument
Applicant
MOOR INSTRUMENTS LTD.
MILLWEY
AXMINSTER, DEVON EX135HU GB
Other 510(k) Applications for this Company
Contact
XIABING HUANG
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
10/16/2008
Decision Date
01/13/2009
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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