FDA 510(k) Application Details - K982748

Device Classification Name	Electrosurgical, Cutting & Coagulation & Accessories   More FDA Info for this Device
510(K) Number	K982748
Device Name	Electrosurgical, Cutting & Coagulation & Accessories
Applicant	NEW DEANTRONICS TAIWAN, LTD. 4655 KIRKWOOD COURT BOULDER, CO 80301 US Other 510(k) Applications for this Company
Contact	LEWIS WARD 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	08/06/1998
Decision Date	11/03/1998
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