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FDA 510(k) Application Details - K072767
Device Classification Name
Powered Laser Surgical Instrument
More FDA Info for this Device
510(K) Number
K072767
Device Name
Powered Laser Surgical Instrument
Applicant
SILVER BAY, LLC
24372 MCCLOUD COURT
LAGUNA NIGUEL, CA 92677 US
Other 510(k) Applications for this Company
Contact
GARY MOCNIK
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
09/28/2007
Decision Date
10/15/2007
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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