510(k) K810313

HAEMONETICS 1400 ML THERAPEUTIC BAG by Haemonetics Corp. — Product Code KSR

K810313 is an FDA 510(k) premarket notification submitted by Haemonetics Corp. for the device "HAEMONETICS 1400 ML THERAPEUTIC BAG". The FDA issued a decision of Substantially Equivalent on March 31, 1981. The device falls under product code KSR (Container, Empty, For Collection & Processing Of Blood & Blood Components), a Class II device regulated under 21 CFR 864.9100. Haemonetics Corp. has at least 10 other 510(k) clearances on record.