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FDA 510(k)

LITHOGOLD

K-Number: K062081 · 2006-11-02

ApplicantTissue Regeneration Technologies, Inc.
Decision Date2006-11-02
Product CodeLNS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

LITHOGOLD is the device name listed in this FDA 510(k) record. The listed applicant is Tissue Regeneration Technologies, Inc.. It received FDA 510(k) clearance on 2006-11-02 under 510(k) number K062081. The device is classified under product code LNS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LITHOGOLD?

LITHOGOLD is a medical device that received FDA 510(k) clearance on 2006-11-02. The listed applicant is Tissue Regeneration Technologies, Inc.. The 510(k) number is K062081.

When did LITHOGOLD receive FDA 510(k) clearance?

LITHOGOLD received FDA 510(k) clearance on 2006-11-02, under 510(k) number K062081.

Who is the listed applicant for LITHOGOLD?

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

What is the FDA product code for LITHOGOLD?

The FDA product code for LITHOGOLD is LNS.

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Related Devices (Code: LNS)

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

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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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