510(k) K801082

GAMBRO HEMOFREEZE-BAG by Gambro, Inc. — Product Code KSR

K801082 is an FDA 510(k) premarket notification submitted by Gambro, Inc. for the device "GAMBRO HEMOFREEZE-BAG". The FDA issued a decision of Substantially Equivalent on October 31, 1980. 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. Gambro, Inc. has at least 10 other 510(k) clearances on record.