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FDA 510(k) Application Details - K080382
Device Classification Name
Powered Laser Surgical Instrument
More FDA Info for this Device
510(K) Number
K080382
Device Name
Powered Laser Surgical Instrument
Applicant
DINONA CO., LTD.
13 RED FOX LANE
LITTLETON, CO 80127 US
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Contact
Kevin Walls
Other 510(k) Applications for this Contact
Regulation Number
878.4810
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Classification Product Code
GEX
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More FDA Info for this Product Code
Date Received
02/13/2008
Decision Date
09/24/2008
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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