510(k) K852135

BSM 21 BLOOD SAFETY MODULE by Hospal Medical Corp. — Product Code KOC

K852135 is an FDA 510(k) premarket notification submitted by Hospal Medical Corp. for the device "BSM 21 BLOOD SAFETY MODULE". The FDA issued a decision of Substantially Equivalent on June 12, 1985. The device falls under product code KOC (Accessories, Blood Circuit, Hemodialysis), a Class II device regulated under 21 CFR 876.5820. Hospal Medical Corp. has at least 10 other 510(k) clearances on record.