510(k) K973076

EUROMEDICAL HAEMATURIA FOLEY CATHETER by Unomedical Sdn Bhd — Product Code EZL

K973076 is an FDA 510(k) premarket notification submitted by Unomedical Sdn Bhd for the device "EUROMEDICAL HAEMATURIA FOLEY CATHETER". The FDA issued a decision of Substantially Equivalent on September 16, 1998. The device falls under product code EZL (Catheter, Retention Type, Balloon), a Class II device regulated under 21 CFR 876.5130. Unomedical Sdn Bhd has at least 10 other 510(k) clearances on record.