Hemospal Kits A1, A2D, Ao, & A1D

FDA 510(k) K901368 · Gambro-Hospal, Inc.

Substantially Equivalent

510(k) numberK901368

Submission

Device name
Hemospal Kits A1, A2D, Ao, & A1D
Applicant
Gambro-Hospal, Inc.
Williamsburg, VA, US
Received
March 23, 1990
Decision date
August 2, 1990
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
FJG – Dialyzer, Parallel Flow
Device class
Class II (moderate risk)
Regulation
21 CFR 876.5820
Specialty
Gastroenterology, Urology
Life-sustaining
Yes

Other 510(k)s with product code FJG

510(k)DeviceApplicantDecision
K933681Gambro Lundia Pro 100, 500, 600 DialyzersFJG · Traditional Cobe Renal Care, Inc.09/07/1994SE
K933680Gambro Lundia Pro 200 DialyzerFJG · Traditional Cobe Renal Care, Inc.08/26/1994SE
K920693Dextrolyte II Peritoneal Dialysis 48-3028-9FJG · Traditional National Medical Care, Medical Products Div., Inc.09/21/1992SE
K915504Gambro Lundia Alpha HemodialyzersFJG · Traditional C.G.H. Medical, Inc.03/06/1992SE
K902203Tenckhoff Peritoneal Dialysis KitFJG · Traditional Akcess Medical Products, Inc.08/01/1990SESK
K862840Gambro Lundia 10-1L, 1N, 1H, 3H, 4N, 4H, 5H, 6NFJG · Traditional Gambro, Inc.09/29/1986SE
K853406Gambro Lundia Pro 3 & 5 DialyzerFJG · Traditional Gambro, Inc.01/08/1986SE
K820694Cobe PPD 1.3L, #18-520-009FJG · Traditional Cobe Laboratories, Inc.03/31/1982SE
K812336Cobe PPD 1.9FJG · Traditional Cobe Laboratories, Inc.08/31/1981SE
K811440Exp 600 Parallel Plate DialyzerFJG · Traditional Extracorporeal Medical Specialities, Inc.06/12/1981SE

More from Extracorporeal Medical Specialities, Inc.

510(k)DeviceDecision
K902588BSM/21&22 SC Blood Safe Mod & V.P.M. Ven Press ModKOC · Traditional 03/07/1991SE
K896068Tipstop(Tm)KGX · Traditional 09/10/1990SE

Questions and answers

When was Hemospal Kits A1, A2D, Ao, & A1D cleared by the FDA?

Hemospal Kits A1, A2D, Ao, & A1D (K901368) received a 510(k) decision of Substantially Equivalent on August 2, 1990, 132 days after the submission was received.

What is the product code of K901368?

The FDA product code is FJG – Dialyzer, Parallel Flow, a Class II (moderate risk) device regulated under 21 CFR 876.5820.