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FDA 510(k)

HEMOSPAL KITS A1, A2D, AO, & A1D

K-Number: K901368 · 1990-08-02

ApplicantGambro-Hospal, Inc.
Decision Date1990-08-02
Product CodeFJG
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

HEMOSPAL KITS A1, A2D, AO, & A1D is the device name listed in this FDA 510(k) record. The listed applicant is Gambro-Hospal, Inc.. It received FDA 510(k) clearance on 1990-08-02 under 510(k) number K901368. The device is classified under product code FJG. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEMOSPAL KITS A1, A2D, AO, & A1D?

HEMOSPAL KITS A1, A2D, AO, & A1D is a medical device that received FDA 510(k) clearance on 1990-08-02. The listed applicant is Gambro-Hospal, Inc.. The 510(k) number is K901368.

When did HEMOSPAL KITS A1, A2D, AO, & A1D receive FDA 510(k) clearance?

HEMOSPAL KITS A1, A2D, AO, & A1D received FDA 510(k) clearance on 1990-08-02, under 510(k) number K901368.

Who is the listed applicant for HEMOSPAL KITS A1, A2D, AO, & A1D?

The FDA 510(k) record lists Gambro-Hospal, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HEMOSPAL KITS A1, A2D, AO, & A1D?

The FDA product code for HEMOSPAL KITS A1, A2D, AO, & A1D is FJG.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Gambro-Hospal, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: FJG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K933681GAMBRO LUNDIA PRO 100, 500, 600 DIALYZERSCobe Renal Care, Inc.K933680GAMBRO LUNDIA PRO 200 DIALYZERCobe Renal Care, Inc.K920693DEXTROLYTE II PERITONEAL DIALYSIS 48-3028-9National Medical Care, Medical Products Div., Inc.K915504GAMBRO LUNDIA ALPHA HEMODIALYZERSC.G.H. Medical, Inc.K902203TENCKHOFF PERITONEAL DIALYSIS KITAkcess Medical Products, Inc.K862840GAMBRO LUNDIA 10-1L, 1N, 1H, 3H, 4N, 4H, 5H, 6NGambro, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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