510(k) K820173

COBE SINGLE-NEEDLE CONTROLLER #18-756 by Cobe Laboratories, Inc. — Product Code FIF

K820173 is an FDA 510(k) premarket notification submitted by Cobe Laboratories, Inc. for the device "COBE SINGLE-NEEDLE CONTROLLER #18-756". The FDA issued a decision of Substantially Equivalent on March 23, 1982. The device falls under product code FIF (Set, Dialysis, Single Needle With Uni-Directional Pump), a Class II device regulated under 21 CFR 876.5820. Cobe Laboratories, Inc. has at least 10 other 510(k) clearances on record.