Gambro Lundia Fiber

FDA 510(k) K800336 · Gambro, Inc.

Substantially Equivalent

510(k) numberK800336

Submission

Device name
Gambro Lundia Fiber
Applicant
Gambro, Inc.
Mchenry, IL, US
Received
February 15, 1980
Decision date
May 2, 1980
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
FJI – Dialyzer, Capillary, Hollow Fiber
Device class
Class II (moderate risk)
Regulation
21 CFR 876.5820
Specialty
Gastroenterology, Urology
Life-sustaining
Yes

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K032431Prisma M60/M100 SetsKDI · Special 09/15/2003SE
K896758Gambro Bicarbonate Monitor BCM 10-3FKP · Traditional 09/28/1990SE
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K902481Gambro Alwall GFS Plus 11, 16 & 20 Hollow FiberFJI · Traditional 07/27/1990SE
K900918Gambro Lundia IC-6H Parallel Plate DialyzerKDI · Traditional 07/16/1990SE
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Questions and answers

When was Gambro Lundia Fiber cleared by the FDA?

Gambro Lundia Fiber (K800336) received a 510(k) decision of Substantially Equivalent on May 2, 1980, 77 days after the submission was received.

What is the product code of K800336?

The FDA product code is FJI – Dialyzer, Capillary, Hollow Fiber, a Class II (moderate risk) device regulated under 21 CFR 876.5820.