FDA 510(k) Application Details - K082643

Device Classification Name	Electrosurgical, Cutting & Coagulation & Accessories   More FDA Info for this Device
510(K) Number	K082643
Device Name	Electrosurgical, Cutting & Coagulation & Accessories
Applicant	DEPUY MITEK, A JOHNSON & JOHNSON COMPANY 325 PARAMOUNT DR. RAYNHAM, MA 02767 US Other 510(k) Applications for this Company
Contact	ZHENG LIU 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	09/11/2008
Decision Date	12/19/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review