FDA 510(k) Application Details - K994010

Device Classification Name	Powered Laser Surgical Instrument   More FDA Info for this Device
510(K) Number	K994010
Device Name	Powered Laser Surgical Instrument
Applicant	INNOVAQUARTZ 4420 SOUTH 32ND ST. PHOENIX, AZ 85040 US Other 510(k) Applications for this Company
Contact	RANDY MCLELLAN 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	11/26/1999
Decision Date	12/17/1999
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