FDA 510(k) Application Details - K981219

Device Classification Name	Electrosurgical, Cutting & Coagulation & Accessories   More FDA Info for this Device
510(K) Number	K981219
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, PHD 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	04/03/1998
Decision Date	06/29/1998
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