FDA 510(k) Application Details - K973590

Device Classification Name	Device, Thermal, Hemorrhoids   More FDA Info for this Device
510(K) Number	K973590
Device Name	Device, Thermal, Hemorrhoids
Applicant	A. STEIN - REGULATORY AFFAIRS CONSULTING P.O.B. 454 GINOT SHOMRON 44853 IL Other 510(k) Applications for this Company
Contact	AHAVA STEIN 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	09/22/1997
Decision Date	02/05/1998
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