510(k) K800723

MICRO-COIL 100 COIL DIALYZER by Erika, Inc. — Product Code FHS

K800723 is an FDA 510(k) premarket notification submitted by Erika, Inc. for the device "MICRO-COIL 100 COIL DIALYZER". The FDA issued a decision of Substantially Equivalent on May 14, 1980. The device falls under product code FHS (Dialyzer, Single Coil), a Class II device regulated under 21 CFR 876.5820. Erika, Inc. has at least 10 other 510(k) clearances on record.