FDA 510(k) Application Details - K001243

Device Classification Name	Powered Laser Surgical Instrument   More FDA Info for this Device
510(K) Number	K001243
Device Name	Powered Laser Surgical Instrument
Applicant	DORNIER SURGICAL PRODUCTS, INC. 8623 N. LAGOON DR. SUITE C3 PANAMA CYT BCH, FL US Other 510(k) Applications for this Company
Contact	JOE D BROWN 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	04/18/2000
Decision Date	05/24/2000
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