510(k) K915065

I.V.IRRIGATION POLE by American Medical Mfg., Inc. — Product Code FOZ

K915065 is an FDA 510(k) premarket notification submitted by American Medical Mfg., Inc. for the device "I.V.IRRIGATION POLE". The FDA issued a decision of Substantially Equivalent on February 11, 1992. The device falls under product code FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days), a Class II device regulated under 21 CFR 880.5200. American Medical Mfg., Inc. has at least 5 other 510(k) clearances on record.