FDA 510(k) Application Details - K012071

Device Classification Name	Powered Laser Surgical Instrument   More FDA Info for this Device
510(K) Number	K012071
Device Name	Powered Laser Surgical Instrument
Applicant	UNION MEDICAL USA 3750 NW 114TH AVE. UNIT #5 MIAMI, FL 33178 US Other 510(k) Applications for this Company
Contact	ANNIE VELEZ 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	07/02/2001
Decision Date	12/03/2001
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