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FDA 510(k)

TRUE

K-Number: K993913 · 2000-08-09

ApplicantInfinity Extrusion & Engineering, Inc.
Decision Date2000-08-09
Product CodeLIT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TRUE is the device name listed in this FDA 510(k) record. The listed applicant is Infinity Extrusion & Engineering, Inc.. It received FDA 510(k) clearance on 2000-08-09 under 510(k) number K993913. The device is classified under product code LIT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRUE?

TRUE is a medical device that received FDA 510(k) clearance on 2000-08-09. The listed applicant is Infinity Extrusion & Engineering, Inc.. The 510(k) number is K993913.

When did TRUE receive FDA 510(k) clearance?

TRUE received FDA 510(k) clearance on 2000-08-09, under 510(k) number K993913.

Who is the listed applicant for TRUE?

The FDA 510(k) record lists Infinity Extrusion & Engineering, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TRUE?

The FDA product code for TRUE is LIT.

Related Devices (Code: LIT)

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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