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FDA 510(k) Application Details - K083748
Device Classification Name
Powered Laser Surgical Instrument
More FDA Info for this Device
510(K) Number
K083748
Device Name
Powered Laser Surgical Instrument
Applicant
CYDEN LIMITED
TECHNIUM, KINGS ROAD
THE DOCKS
SWANSEA, WALES SA1 8PH GB
Other 510(k) Applications for this Company
Contact
MICHAEL KIERNAN
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
12/17/2008
Decision Date
02/02/2009
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Statement
Type
Special
Reviewed By Third Party
N
Expedited Review
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