FDA 510(k) Application Details - K113021

Device Classification Name	Unit, Cryosurgical, Accessories   More FDA Info for this Device
510(K) Number	K113021
Device Name	Unit, Cryosurgical, Accessories
Applicant	CSA MEDICAL, INC. 1447 York Rd Ste 610 Lutherville, MD 21093 US Other 510(k) Applications for this Company
Contact	COLLEEN KISTLER 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	10/11/2011
Decision Date	02/07/2012
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