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FDA 510(k)

Oniko nail brace

K-Number: K162525 · 2018-04-25

Decision Date2018-04-25
Product CodeMQZ
DecisionSubstantially Equivalent

Device Summary

Oniko nail brace is the device name listed in this FDA 510(k) record. The listed applicant is Begum Saglik Hizmetleri Tibbi Malzemeler Danismanlik Lsti. It received FDA 510(k) clearance on 2018-04-25 under 510(k) number K162525. The device is classified under product code MQZ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Oniko nail brace?

Oniko nail brace is a medical device that received FDA 510(k) clearance on 2018-04-25. The listed applicant is Begum Saglik Hizmetleri Tibbi Malzemeler Danismanlik Lsti. The 510(k) number is K162525.

When did Oniko nail brace receive FDA 510(k) clearance?

Oniko nail brace received FDA 510(k) clearance on 2018-04-25, under 510(k) number K162525.

Who is the listed applicant for Oniko nail brace?

The FDA 510(k) record lists Begum Saglik Hizmetleri Tibbi Malzemeler Danismanlik Lsti as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Oniko nail brace?

The FDA product code for Oniko nail brace is MQZ.

Related Devices (Code: MQZ)

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.