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FDA 510(k) Application Details - K964831
Device Classification Name
Powered Laser Surgical Instrument
More FDA Info for this Device
510(K) Number
K964831
Device Name
Powered Laser Surgical Instrument
Applicant
CLINICON CORP.
2260 RUTHERFORD RD., #101
CARLSBAD, CA 92008 US
Other 510(k) Applications for this Company
Contact
ALAN BUNTING
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
12/02/1996
Decision Date
08/08/1997
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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