FDA 510(k) Application Details - K113660

Device Classification Name	Device, Thermal, Hemorrhoids   More FDA Info for this Device
510(K) Number	K113660
Device Name	Device, Thermal, Hemorrhoids
Applicant	CRYOTHERAPY PRODUCTS INC. 1804 SW 81 TERRACE DAVIE, FL 33324 US Other 510(k) Applications for this Company
Contact	JORGE CABALLERO Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	LKX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/13/2011
Decision Date	05/03/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review