FDA 510(k) Application Details - K982860

Device Classification Name	Powered Laser Surgical Instrument   More FDA Info for this Device
510(K) Number	K982860
Device Name	Powered Laser Surgical Instrument
Applicant	UNION MEDICAL ENGENEERING CO., LTD. 8930 S.W. 68TH COURT #H3 MIAMI, FL 33156 US Other 510(k) Applications for this Company
Contact	ANNIE VALEZ 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	08/13/1998
Decision Date	08/13/1999
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