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FDA 510(k)

NEEDLE, DIALYSIS

K-Number: K902564 · 1991-03-01

ApplicantGainor Medical Europe, Ltd.
Decision Date1991-03-01
Product CodeFIE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

NEEDLE, DIALYSIS is the device name listed in this FDA 510(k) record. The listed applicant is Gainor Medical Europe, Ltd.. It received FDA 510(k) clearance on 1991-03-01 under 510(k) number K902564. The device is classified under product code FIE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEEDLE, DIALYSIS?

NEEDLE, DIALYSIS is a medical device that received FDA 510(k) clearance on 1991-03-01. The listed applicant is Gainor Medical Europe, Ltd.. The 510(k) number is K902564.

When did NEEDLE, DIALYSIS receive FDA 510(k) clearance?

NEEDLE, DIALYSIS received FDA 510(k) clearance on 1991-03-01, under 510(k) number K902564.

Who is the listed applicant for NEEDLE, DIALYSIS?

The FDA 510(k) record lists Gainor Medical Europe, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NEEDLE, DIALYSIS?

The FDA product code for NEEDLE, DIALYSIS is FIE.

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Other records listing Gainor Medical Europe, Ltd. as applicant

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Related Devices (Code: FIE)

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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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