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FDA 510(k)

GCS-79

K-Number: K801921 · 1980-10-31

Decision Date1980-10-31
Product CodeGEH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

GCS-79 is the device name listed in this FDA 510(k) record. The listed applicant is Gilmore Liquid Air Co.. It received FDA 510(k) clearance on 1980-10-31 under 510(k) number K801921. The device is classified under product code GEH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GCS-79?

GCS-79 is a medical device that received FDA 510(k) clearance on 1980-10-31. The listed applicant is Gilmore Liquid Air Co.. The 510(k) number is K801921.

When did GCS-79 receive FDA 510(k) clearance?

GCS-79 received FDA 510(k) clearance on 1980-10-31, under 510(k) number K801921.

Who is the listed applicant for GCS-79?

The FDA 510(k) record lists Gilmore Liquid Air Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GCS-79?

The FDA product code for GCS-79 is GEH.

Other records listing Gilmore Liquid Air Co. 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.

Related Devices (Code: GEH)

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.

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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