Product code FKI

Device name: Set, Dialyzer Holder
Medical specialty: Gastroenterology, Urology
Device class: 2
Regulation number: 876.5820
Review panel: GU
Implant: N
Life sustaining/supporting: N
GMP exempt: N
Third party review: N
Summary malfunction reporting: Eligible
Source: FDA openFDA device classification dataset

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K843504	AMER. BENTLEY HEMOFILTER HOLDER HFH-1	American Bentley	1984-10-18
K811292	PARALLEL PLATE DIALYZER HOLDER	Extracorporeal Medical Specialities, Inc.	1981-06-02
K802075	HOLLOW FIBER DIALYZER HOLDER	Renal Devices, Inc.	1980-09-16