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FDA 510(k)

TEMP-GUARD TM

K-Number: K790948 · 1979-09-24

Decision Date1979-09-24
Product CodeFMT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

TEMP-GUARD TM is the device name listed in this FDA 510(k) record. The listed applicant is Gordon Consultants, Inc.. It received FDA 510(k) clearance on 1979-09-24 under 510(k) number K790948. The device is classified under product code FMT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TEMP-GUARD TM?

TEMP-GUARD TM is a medical device that received FDA 510(k) clearance on 1979-09-24. The listed applicant is Gordon Consultants, Inc.. The 510(k) number is K790948.

When did TEMP-GUARD TM receive FDA 510(k) clearance?

TEMP-GUARD TM received FDA 510(k) clearance on 1979-09-24, under 510(k) number K790948.

Who is the listed applicant for TEMP-GUARD TM?

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

What is the FDA product code for TEMP-GUARD TM?

The FDA product code for TEMP-GUARD TM is FMT.

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.

Related Devices (Code: FMT)

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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