FDA 510(k) Application Details - K172049

Device Classification Name	Unit, Cryosurgical, Accessories   More FDA Info for this Device
510(K) Number	K172049
Device Name	Unit, Cryosurgical, Accessories
Applicant	Cry IQ AB Apelrodsvagen 1 Onsala 43932 SE Other 510(k) Applications for this Company
Contact	Stefan Skafte 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	07/06/2017
Decision Date	08/30/2017
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