FDA 510(k) Application Details - K110462

Device Classification Name	Electrosurgical, Cutting & Coagulation & Accessories   More FDA Info for this Device
510(K) Number	K110462
Device Name	Electrosurgical, Cutting & Coagulation & Accessories
Applicant	KEPLER MEDTEC 200 Homer Ave Ashland, MA 01721 US Other 510(k) Applications for this Company
Contact	SHARYN ORTON, PHD 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	02/17/2011
Decision Date	09/26/2011
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