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FDA 510(k)

TRAY-LINK

K-Number: K992001 · 1999-11-02

Decision Date1999-11-02
Product CodeELW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TRAY-LINK is the device name listed in this FDA 510(k) record. The listed applicant is Silicon-Und Composite Spezialitaten GmbH. It received FDA 510(k) clearance on 1999-11-02 under 510(k) number K992001. The device is classified under product code ELW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRAY-LINK?

TRAY-LINK is a medical device that received FDA 510(k) clearance on 1999-11-02. The listed applicant is Silicon-Und Composite Spezialitaten GmbH. The 510(k) number is K992001.

When did TRAY-LINK receive FDA 510(k) clearance?

TRAY-LINK received FDA 510(k) clearance on 1999-11-02, under 510(k) number K992001.

Who is the listed applicant for TRAY-LINK?

The FDA 510(k) record lists Silicon-Und Composite Spezialitaten GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TRAY-LINK?

The FDA product code for TRAY-LINK is ELW.

Other records listing Silicon-Und Composite Spezialitaten GmbH as applicant

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.

Related Devices (Code: ELW)

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.

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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