FDA 510(k) Application Details - K981428

Device Classification Name	Device, Thermal, Hemorrhoids   More FDA Info for this Device
510(K) Number	K981428
Device Name	Device, Thermal, Hemorrhoids
Applicant	CRYOPTHERAPY PAIN RELIEF PRODUCTS, INC. 272 N.W.106 TERRACE PEMBROKE PINES, FL 33026 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	04/20/1998
Decision Date	07/07/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review