FDA 510(k) Application Details - K955612

Device Classification Name	Powered Laser Surgical Instrument   More FDA Info for this Device
510(K) Number	K955612
Device Name	Powered Laser Surgical Instrument
Applicant	SPECTRUM MEDICAL TECHNOLOGIES, INC. 3499 WOODLEY PARK PL. OVIDEO, FL 32765 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	12/08/1995
Decision Date	07/09/1996
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