FDA 510(k) Application Details - K003462

Device Classification Name	Electrosurgical, Cutting & Coagulation & Accessories   More FDA Info for this Device
510(K) Number	K003462
Device Name	Electrosurgical, Cutting & Coagulation & Accessories
Applicant	ERBE USA, INC. 2275 NORTHWEST PKWY., STE. 105 MARIETTA, GA 30067 US Other 510(k) Applications for this Company
Contact	JOHN TARTAL 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	11/07/2000
Decision Date	01/04/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review