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FDA 510(k)

Reza Band, Reflux Band

K-Number: K173934 · 2018-04-13

ApplicantSomna Therapeutics, LLC
Decision Date2018-04-13
Product CodePKA
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

Reza Band, Reflux Band is a medical device manufactured by Somna Therapeutics, LLC. It received FDA 510(k) clearance on 2018-04-13 under approval number K173934. The device is classified under product code PKA. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Reza Band, Reflux Band?

Reza Band, Reflux Band is a medical device that received FDA 510(k) clearance on 2018-04-13. It is manufactured by Somna Therapeutics, LLC. The 510(k) number is K173934.

When was Reza Band, Reflux Band approved by the FDA?

Reza Band, Reflux Band received FDA 510(k) clearance on 2018-04-13, under approval number K173934.

What company makes Reza Band, Reflux Band?

Reza Band, Reflux Band is manufactured by Somna Therapeutics, LLC.

What is the FDA product code for Reza Band, Reflux Band?

The FDA product code for Reza Band, Reflux Band is PKA.

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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