510(k) K820694

COBE PPD 1.3L, #18-520-009 by Cobe Laboratories, Inc. — Product Code FJG

K820694 is an FDA 510(k) premarket notification submitted by Cobe Laboratories, Inc. for the device "COBE PPD 1.3L, #18-520-009". The FDA issued a decision of Substantially Equivalent on Mar 31, 1982. The device falls under product code FJG (Dialyzer, Parallel Flow), a Class II device regulated under 21 CFR 876.5820. Cobe Laboratories, Inc. has 76 other 510(k) clearances on record.