FDA 510(k) Application Details - K162608

Device Classification Name	Unit, Cryosurgical, Accessories   More FDA Info for this Device
510(K) Number	K162608
Device Name	Unit, Cryosurgical, Accessories
Applicant	ARRINEX, INC. 1755 EAST BAYSHORE RD, STE 26 REDWOOD CITY, CA 94063 US Other 510(k) Applications for this Company
Contact	VAHID SAADAT 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	09/19/2016
Decision Date	02/14/2017
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