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FDA 510(k)

Urbanek Device

K-Number: K170985 · 2017-09-25

ApplicantTmj Services, LLC
Decision Date2017-09-25
Product CodeMQC
DecisionSubstantially Equivalent

Device Summary

Urbanek Device is a medical device manufactured by Tmj Services, LLC. It received FDA 510(k) clearance on 2017-09-25 under approval number K170985. The device is classified under product code MQC. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Urbanek Device?

Urbanek Device is a medical device that received FDA 510(k) clearance on 2017-09-25. It is manufactured by Tmj Services, LLC. The 510(k) number is K170985.

When was Urbanek Device approved by the FDA?

Urbanek Device received FDA 510(k) clearance on 2017-09-25, under approval number K170985.

What company makes Urbanek Device?

Urbanek Device is manufactured by Tmj Services, LLC.

What is the FDA product code for Urbanek Device?

The FDA product code for Urbanek Device is MQC.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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