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FDA 510(k)

GAMBRO ALWALL GFE 8 & 9 HOLLOW FIBER DIALYZER

K-Number: K890111 · 1989-02-08

ApplicantGambro, Inc.
Decision Date1989-02-08
Product CodeFJI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

GAMBRO ALWALL GFE 8 & 9 HOLLOW FIBER DIALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Gambro, Inc.. It received FDA 510(k) clearance on 1989-02-08 under 510(k) number K890111. The device is classified under product code FJI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GAMBRO ALWALL GFE 8 & 9 HOLLOW FIBER DIALYZER?

GAMBRO ALWALL GFE 8 & 9 HOLLOW FIBER DIALYZER is a medical device that received FDA 510(k) clearance on 1989-02-08. The listed applicant is Gambro, Inc.. The 510(k) number is K890111.

When did GAMBRO ALWALL GFE 8 & 9 HOLLOW FIBER DIALYZER receive FDA 510(k) clearance?

GAMBRO ALWALL GFE 8 & 9 HOLLOW FIBER DIALYZER received FDA 510(k) clearance on 1989-02-08, under 510(k) number K890111.

Who is the listed applicant for GAMBRO ALWALL GFE 8 & 9 HOLLOW FIBER DIALYZER?

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

What is the FDA product code for GAMBRO ALWALL GFE 8 & 9 HOLLOW FIBER DIALYZER?

The FDA product code for GAMBRO ALWALL GFE 8 & 9 HOLLOW FIBER DIALYZER is FJI.

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Other records listing Gambro, 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: FJI)

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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Official Source

View on FDA Database →

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

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