510(k) K862015

O.2 MICRON INFECTION RESISTANT HYDROPHOBIC FILTER by Bipore, Inc. — Product Code FIB

K862015 is an FDA 510(k) premarket notification submitted by Bipore, Inc. for the device "O.2 MICRON INFECTION RESISTANT HYDROPHOBIC FILTER". The FDA issued a decision of Substantially Equivalent on July 22, 1986. The device falls under product code FIB (Protector, Transducer, Dialysis), a Class II device regulated under 21 CFR 876.5820. Bipore, Inc. has at least 9 other 510(k) clearances on record.