510(k) K910321

Y ADAPTOR by Akcess Medical Products, Inc. — Product Code KOC

K910321 is an FDA 510(k) premarket notification submitted by Akcess Medical Products, Inc. for the device "Y ADAPTOR". The FDA issued a decision of Substantially Equivalent on April 16, 1991. The device falls under product code KOC (Accessories, Blood Circuit, Hemodialysis), a Class II device regulated under 21 CFR 876.5820. Akcess Medical Products, Inc. has at least 10 other 510(k) clearances on record.