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FDA 510(k) Application Details - K063834
Device Classification Name
Powered Laser Surgical Instrument
More FDA Info for this Device
510(K) Number
K063834
Device Name
Powered Laser Surgical Instrument
Applicant
HOYA CONBIO, INC
1105 SUNSET CREEK LANE
PLEASANTON, CA 94566 US
Other 510(k) Applications for this Company
Contact
DONNA TEMPLEMAN
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
12/26/2006
Decision Date
01/25/2007
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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