FDA 510(k) Application Details - K991297

Device Classification Name	Powered Laser Surgical Instrument   More FDA Info for this Device
510(K) Number	K991297
Device Name	Powered Laser Surgical Instrument
Applicant	MEDART CORP. 11772 SORRENTO VALLEY RD. #234 SAN DIEGO, CA 92121 US Other 510(k) Applications for this Company
Contact	MARILYN M CHOU 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	04/15/1999
Decision Date	07/12/1999
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