FDA 510(k) Application Details - K151054

Device Classification Name	Unit, Cryosurgical, Accessories   More FDA Info for this Device
510(K) Number	K151054
Device Name	Unit, Cryosurgical, Accessories
Applicant	C2 Therapeutics, Inc. 303 Convention Way, Suite 1 Redwood City, CA 94063 US Other 510(k) Applications for this Company
Contact	Theresa Brandner-Allen Other 510(k) Applications for this Contact
Regulation Number	878.4350   More FDA Info for this Regulation Number
Classification Product Code	GEH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/20/2015
Decision Date	07/07/2015
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