FDA 510(k) Application Details - K161296

Device Classification Name	Unit, Cryosurgical, Accessories   More FDA Info for this Device
510(K) Number	K161296
Device Name	Unit, Cryosurgical, Accessories
Applicant	COOL RENEWAL, LLC 2515 EUGENIA AVENUE, SUITE 103 NASHVILLE, TN 37211 US Other 510(k) Applications for this Company
Contact	ASHLEY RAINS 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	05/09/2016
Decision Date	07/06/2016
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