510(k) K781102

DIALYZER, DISP., COIL, LUNDIA by Gambro, Inc. — Product Code FHS

K781102 is an FDA 510(k) premarket notification submitted by Gambro, Inc. for the device "DIALYZER, DISP., COIL, LUNDIA". The FDA issued a decision of Substantially Equivalent on October 17, 1978. The device falls under product code FHS (Dialyzer, Single Coil), a Class II device regulated under 21 CFR 876.5820. Gambro, Inc. has at least 10 other 510(k) clearances on record.