FDA 510(k) Application Details - K982612

Device Classification Name	Device, Vein Location, Liquid Crystal   More FDA Info for this Device
510(K) Number	K982612
Device Name	Device, Vein Location, Liquid Crystal
Applicant	IRONMASTER, INC. 1719 GRANT ST. SANTA CLARA, CA 95050 US Other 510(k) Applications for this Company
Contact	FRED DAWSON Other 510(k) Applications for this Contact
Regulation Number	880.6970   More FDA Info for this Regulation Number
Classification Product Code	KZA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/27/1998
Decision Date	12/14/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review