FDA 510(k) Application Details - K181741

Device Classification Name	Unit, Cryosurgical, Accessories   More FDA Info for this Device
510(K) Number	K181741
Device Name	Unit, Cryosurgical, Accessories
Applicant	Galil Medical Ltd. Tavor 1 Building, Industrial Park, PO Box 224 Yokneam 2069203 IL Other 510(k) Applications for this Company
Contact	Stacey Backlund 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	07/02/2018
Decision Date	07/30/2018
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