510(k) K820435

BAXA ADDISEAL by Baxa Corp., Sub. of Cook Group, Inc. — Product Code KPE

K820435 is an FDA 510(k) premarket notification submitted by Baxa Corp., Sub. of Cook Group, Inc. for the device "BAXA ADDISEAL". The FDA issued a decision of Substantially Equivalent on March 8, 1982. The device falls under product code KPE (Container, I.V.), a Class II device regulated under 21 CFR 880.5025. Baxa Corp., Sub. of Cook Group, Inc. has at least 10 other 510(k) clearances on record.