FDA 510(k) Application Details - K012725

Device Classification Name	Electrosurgical, Cutting & Coagulation & Accessories   More FDA Info for this Device
510(K) Number	K012725
Device Name	Electrosurgical, Cutting & Coagulation & Accessories
Applicant	ENDO-THERAPEUTICS, INC. 1183 CEDAR ST. SAFETY HARBOR, FL 34695-2908 US Other 510(k) Applications for this Company
Contact	TODD ADKISSON Other 510(k) Applications for this Contact
Regulation Number	878.4400   More FDA Info for this Regulation Number
Classification Product Code	GEI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/15/2001
Decision Date	11/08/2001
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