510(k) K896750

LOFRIC(R), LOFRIC(R) CATH-KIT by Astra Meditec AB — Product Code KOD

K896750 is an FDA 510(k) premarket notification submitted by Astra Meditec AB for the device "LOFRIC(R), LOFRIC(R) CATH-KIT". The FDA issued a decision of Substantially Equivalent on August 6, 1990. The device falls under product code KOD (Catheter, Urological), a Class II device regulated under 21 CFR 876.5130. Astra Meditec AB has at least 2 other 510(k) clearances on record.