510(k) K990500

KENDALL ULTRAMER COUDE FOLEY CATHETER, MODEL 1416C, KENDALL CURITY COUDE FOLEY CATHETER TRAY, MODEL 6946C by The Kendal Co. — Product Code EZL

K990500 is an FDA 510(k) premarket notification submitted by The Kendal Co. for the device "KENDALL ULTRAMER COUDE FOLEY CATHETER, MODEL 1416C, KENDALL CURITY COUDE FOLEY CATHETER TRAY, MODEL 6946C". The FDA issued a decision of Substantially Equivalent on September 28, 1999. The device falls under product code EZL (Catheter, Retention Type, Balloon), a Class II device regulated under 21 CFR 876.5130. The Kendal Co. has at least 10 other 510(k) clearances on record.