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FDA 510(k) Application Details - K011021
Device Classification Name
Powered Laser Surgical Instrument
More FDA Info for this Device
510(K) Number
K011021
Device Name
Powered Laser Surgical Instrument
Applicant
YA-MAN LTD
5818 PRINCESS CAROLINE PLACE
LEESBURG, FL 34748 US
Other 510(k) Applications for this Company
Contact
ROBERT T HANDREN
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
04/04/2001
Decision Date
10/09/2001
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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