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FDA 510(k)

TRACHE-TITE

K-Number: K950930 · 1995-03-22

ApplicantThe Varner Group, Inc.
Decision Date1995-03-22
Product CodeCBH
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

TRACHE-TITE is the device name listed in this FDA 510(k) record. The listed applicant is The Varner Group, Inc.. It received FDA 510(k) clearance on 1995-03-22 under 510(k) number K950930. The device is classified under product code CBH. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRACHE-TITE?

TRACHE-TITE is a medical device that received FDA 510(k) clearance on 1995-03-22. The listed applicant is The Varner Group, Inc.. The 510(k) number is K950930.

When did TRACHE-TITE receive FDA 510(k) clearance?

TRACHE-TITE received FDA 510(k) clearance on 1995-03-22, under 510(k) number K950930.

Who is the listed applicant for TRACHE-TITE?

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

What is the FDA product code for TRACHE-TITE?

The FDA product code for TRACHE-TITE is CBH.

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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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