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FDA 510(k)

Duracetal

K-Number: K172407 · 2017-11-02

ApplicantThe Myerson Company Limited
Decision Date2017-11-02
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Duracetal is a medical device manufactured by The Myerson Company Limited. It received FDA 510(k) clearance on 2017-11-02 under approval 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. It is manufactured by The Myerson Company Limited. The 510(k) number is K172407.

When was Duracetal approved by the FDA?

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

What company makes Duracetal?

Duracetal is manufactured by The Myerson Company Limited.

What is the FDA product code for Duracetal?

The FDA product code for Duracetal is EBI.

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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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