FDA 510(k) Application Details - K152317

Device Classification Name	Electrosurgical, Cutting & Coagulation & Accessories   More FDA Info for this Device
510(K) Number	K152317
Device Name	Electrosurgical, Cutting & Coagulation & Accessories
Applicant	MEDERI THERAPEUTICS INC. 800 Connecticut Ave, 1E01 Norwalk, CT 06854 US Other 510(k) Applications for this Company
Contact	Oleg Shikhman 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	08/17/2015
Decision Date	09/23/2015
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