FDA 510(k) Application Details - K954911

Device Classification Name	Powered Laser Surgical Instrument   More FDA Info for this Device
510(K) Number	K954911
Device Name	Powered Laser Surgical Instrument
Applicant	GYNE-TECH INSTRUMENT CORP. 2819 BURTON ST. BURBANK, CA 91504 US Other 510(k) Applications for this Company
Contact	J. KERMIT FLOYD 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	10/25/1995
Decision Date	01/24/1996
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