FDA 510(k) Application Details - K183213

Device Classification Name	Unit, Cryosurgical, Accessories   More FDA Info for this Device
510(K) Number	K183213
Device Name	Unit, Cryosurgical, Accessories
Applicant	IceCure Medical LTD. 7 Haeshel St., P.O. Box 3163 Caesarea 3088900 IL Other 510(k) Applications for this Company
Contact	Elisabeth Sadka 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	11/19/2018
Decision Date	12/20/2019
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