510(k) K904474

HAEMONETICS LN 200F COLLECTION RESERVOIR by Haemonetics Corp. — Product Code CAC

K904474 is an FDA 510(k) premarket notification submitted by Haemonetics Corp. for the device "HAEMONETICS LN 200F COLLECTION RESERVOIR". The FDA issued a decision of Substantially Equivalent on November 13, 1990. The device falls under product code CAC (Apparatus, Autotransfusion), a Class II device regulated under 21 CFR 868.5830. Haemonetics Corp. has at least 10 other 510(k) clearances on record.