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FDA 510(k) Application Details - K992061
Device Classification Name
Powered Laser Surgical Instrument
More FDA Info for this Device
510(K) Number
K992061
Device Name
Powered Laser Surgical Instrument
Applicant
LASERMED, INC.
8050 SOUTH 1300 WEST
WEST JORDAN, UT 84088 US
Other 510(k) Applications for this Company
Contact
CALVIN D 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
06/18/1999
Decision Date
07/30/1999
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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