FDA 510(k) Application Details - K083461

Device Classification Name	Electrosurgical, Cutting & Coagulation & Accessories   More FDA Info for this Device
510(K) Number	K083461
Device Name	Electrosurgical, Cutting & Coagulation & Accessories
Applicant	ENDYMION MEDICAL LTD 31 HAAVODA ST. BINYAMINA 30500 IL Other 510(k) Applications for this Company
Contact	YORAM LEVY 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	11/21/2008
Decision Date	07/24/2009
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