510(k) K894978

BACTERIAL FILTER by Med-Tek Corp. — Product Code CAH

K894978 is an FDA 510(k) premarket notification submitted by Med-Tek Corp. for the device "BACTERIAL FILTER". The FDA issued a decision of Substantially Equivalent on November 2, 1989. The device falls under product code CAH (Filter, Bacterial, Breathing-Circuit), a Class II device regulated under 21 CFR 868.5260. Med-Tek Corp. has at least 10 other 510(k) clearances on record.