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FDA 510(k)

OMEGATRAC BY TEFTEC

K-Number: K955240 · 1996-07-01

ApplicantTeftec Corp.
Decision Date1996-07-01
Product CodeITI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

OMEGATRAC BY TEFTEC is the device name listed in this FDA 510(k) record. The listed applicant is Teftec Corp.. It received FDA 510(k) clearance on 1996-07-01 under 510(k) number K955240. The device is classified under product code ITI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OMEGATRAC BY TEFTEC?

OMEGATRAC BY TEFTEC is a medical device that received FDA 510(k) clearance on 1996-07-01. The listed applicant is Teftec Corp.. The 510(k) number is K955240.

When did OMEGATRAC BY TEFTEC receive FDA 510(k) clearance?

OMEGATRAC BY TEFTEC received FDA 510(k) clearance on 1996-07-01, under 510(k) number K955240.

Who is the listed applicant for OMEGATRAC BY TEFTEC?

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

What is the FDA product code for OMEGATRAC BY TEFTEC?

The FDA product code for OMEGATRAC BY TEFTEC is ITI.

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Other records listing Teftec Corp. as applicant

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Related Devices (Code: ITI)

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.

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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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