FDA 510(k) Application Details - K010112

Device Classification Name	Electrosurgical, Cutting & Coagulation & Accessories   More FDA Info for this Device
510(K) Number	K010112
Device Name	Electrosurgical, Cutting & Coagulation & Accessories
Applicant	ENABLE MEDICAL CORP. 6345 CENTRE PARK DR. WEST CHESTER, OH 45069-3863 US Other 510(k) Applications for this Company
Contact	MARK L FRIEDMAN 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	01/12/2001
Decision Date	04/02/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review