FDA 510(k) Application Details - K083590

Device Classification Name	Electrosurgical, Cutting & Coagulation & Accessories   More FDA Info for this Device
510(K) Number	K083590
Device Name	Electrosurgical, Cutting & Coagulation & Accessories
Applicant	ISKRA MEDICAL, D.O.O. STEGNE 23 LJUBLJANA 1000 SI Other 510(k) Applications for this Company
Contact	MOJCA VALJAVEC 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	12/04/2008
Decision Date	04/17/2009
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