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FDA 510(k)

THERMOGARD & THERMOGARD PLUS ABC

K-Number: K972628 · 1997-08-27

ApplicantConmedcorp
Decision Date1997-08-27
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

THERMOGARD & THERMOGARD PLUS ABC is the device name listed in this FDA 510(k) record. The listed applicant is Conmedcorp. It received FDA 510(k) clearance on 1997-08-27 under 510(k) number K972628. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THERMOGARD & THERMOGARD PLUS ABC?

THERMOGARD & THERMOGARD PLUS ABC is a medical device that received FDA 510(k) clearance on 1997-08-27. The listed applicant is Conmedcorp. The 510(k) number is K972628.

When did THERMOGARD & THERMOGARD PLUS ABC receive FDA 510(k) clearance?

THERMOGARD & THERMOGARD PLUS ABC received FDA 510(k) clearance on 1997-08-27, under 510(k) number K972628.

Who is the listed applicant for THERMOGARD & THERMOGARD PLUS ABC?

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

What is the FDA product code for THERMOGARD & THERMOGARD PLUS ABC?

The FDA product code for THERMOGARD & THERMOGARD PLUS ABC is GEI.

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Related Devices (Code: GEI)

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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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