FDA 510(k)

Duracetal

K-Number: K172407 · 2017-11-02

Decision Date2017-11-02

Product CodeEBI

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

Duracetal is the device name listed in this FDA 510(k) record. The listed applicant is The Myerson Company Limited. It received FDA 510(k) clearance on 2017-11-02 under 510(k) number K172407. The device is classified under product code EBI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Duracetal?

Duracetal is a medical device that received FDA 510(k) clearance on 2017-11-02. The listed applicant is The Myerson Company Limited. The 510(k) number is K172407.

When did Duracetal receive FDA 510(k) clearance?

Duracetal received FDA 510(k) clearance on 2017-11-02, under 510(k) number K172407.

Who is the listed applicant for Duracetal?

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

What is the FDA product code for Duracetal?

The FDA product code for Duracetal is EBI.

Related Devices (Code: EBI)

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.