FDA 510(k) Application Details - K000158

Device Classification Name	Powered Laser Surgical Instrument   More FDA Info for this Device
510(K) Number	K000158
Device Name	Powered Laser Surgical Instrument
Applicant	FISMA, INC. 3959 WEST 1820 SOUTH SALT LAKE CITY, UT 84104 US Other 510(k) Applications for this Company
Contact	DOUGLAS A KANE 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	01/19/2000
Decision Date	08/24/2000
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