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FDA 510(k) Application Details - K001746
Device Classification Name
Powered Laser Surgical Instrument
More FDA Info for this Device
510(K) Number
K001746
Device Name
Powered Laser Surgical Instrument
Applicant
COHERENT STAR
1249 QUARRY LN.
SUITE 100
PLEASANTON, CA 94566 US
Other 510(k) Applications for this Company
Contact
ILIRIJA ENCINAS
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
06/08/2000
Decision Date
07/19/2000
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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