FDA 510(k) Application Details - K143564

Device Classification Name	Unit, Cryosurgical, Accessories   More FDA Info for this Device
510(K) Number	K143564
Device Name	Unit, Cryosurgical, Accessories
Applicant	GALIL MEDICAL INC. 4264 Round Lake Road Arden Hills, MN 55112 US Other 510(k) Applications for this Company
Contact	AMY MCKINNEY 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	12/16/2014
Decision Date	03/05/2015
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