510(k) K802361

DIALYIS START CARE KIT by Med-Pak Corp. — Product Code FKG

K802361 is an FDA 510(k) premarket notification submitted by Med-Pak Corp. for the device "DIALYIS START CARE KIT". The FDA issued a decision of Substantially Equivalent on January 16, 1981. The device falls under product code FKG (Tray, Start/Stop (Including Contents), Dialysis), a Class I device regulated under 21 CFR 876.5820. Med-Pak Corp. has at least 1 other 510(k) clearance on record.