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FDA 510(k) Application Details - K080975
Device Classification Name
Powered Laser Surgical Instrument
More FDA Info for this Device
510(K) Number
K080975
Device Name
Powered Laser Surgical Instrument
Applicant
KERA HARVEST/LASER MAX MEDICAL TECHNOLOGIES CORP
1601 NORTH CLANCY STREET
VISALIA, CA 93291-9263 US
Other 510(k) Applications for this Company
Contact
PAUL Y FANG
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
04/07/2008
Decision Date
07/15/2008
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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