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FDA 510(k) Application Details - K100474
Device Classification Name
Powered Laser Surgical Instrument
More FDA Info for this Device
510(K) Number
K100474
Device Name
Powered Laser Surgical Instrument
Applicant
QUICKLASE LIMITED
PO BOX 1264,
1094 WEST GREASEWOOD DRIVE
RIVERTON, UT 84065 US
Other 510(k) Applications for this Company
Contact
CALVIN OSTLER
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
02/18/2010
Decision Date
03/16/2010
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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