510(k) K955149

MAXI-FLOW SUCTION HANDLE/THE REEL THING TUBING REEL by Bio-Medical Devices, Inc. — Product Code BYY

K955149 is an FDA 510(k) premarket notification submitted by Bio-Medical Devices, Inc. for the device "MAXI-FLOW SUCTION HANDLE/THE REEL THING TUBING REEL". The FDA issued a decision of Substantially Equivalent on January 24, 1996. The device falls under product code BYY (Tube, Aspirating, Flexible, Connecting), a Class II device regulated under 21 CFR 880.6740. Bio-Medical Devices, Inc. has at least 6 other 510(k) clearances on record.