Hollow Fiber Dialyzer Holder

FDA 510(k) K802075 · Renal Devices, Inc.

Substantially Equivalent

510(k) numberK802075

Submission

Device name
Hollow Fiber Dialyzer Holder
Applicant
Renal Devices, Inc.
Mchenry, IL, US
Received
August 27, 1980
Decision date
September 16, 1980
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
FKI – Set, Dialyzer Holder
Device class
Class II (moderate risk)
Regulation
21 CFR 876.5820
Specialty
Gastroenterology, Urology

Other 510(k)s with product code FKI

510(k)DeviceApplicantDecision
K843504Amer. Bentley Hemofilter Holder HFH-1FKI · Traditional American Bentley10/18/1984SE
K811292Parallel Plate Dialyzer HolderFKI · Traditional Extracorporeal Medical Specialities, Inc.06/02/1981SE

More from Extracorporeal Medical Specialities, Inc.

510(k)DeviceDecision
K810612HemophronFKQ · Traditional 04/29/1981SE
K801559Hollo Fiber DialyzerFJI · Traditional 10/31/1980SE
K790696RDI-1 Hollow Fiber DialyzerFJI · Traditional 06/20/1979SE

Questions and answers

When was Hollow Fiber Dialyzer Holder cleared by the FDA?

Hollow Fiber Dialyzer Holder (K802075) received a 510(k) decision of Substantially Equivalent on September 16, 1980, 20 days after the submission was received.

What is the product code of K802075?

The FDA product code is FKI – Set, Dialyzer Holder, a Class II (moderate risk) device regulated under 21 CFR 876.5820.