FDA 510(k)

Hydris Oral Rinse

K-Number: K163029 · 2017-06-19

Decision Date2017-06-19

Product CodeLFD

DecisionSubstantially Equivalent

Device Summary

Hydris Oral Rinse is a medical device manufactured by Biopharm Consult, LLC. It received FDA 510(k) clearance on 2017-06-19 under approval number K163029. The device is classified under product code LFD. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Hydris Oral Rinse?

Hydris Oral Rinse is a medical device that received FDA 510(k) clearance on 2017-06-19. It is manufactured by Biopharm Consult, LLC. The 510(k) number is K163029.

When was Hydris Oral Rinse approved by the FDA?

Hydris Oral Rinse received FDA 510(k) clearance on 2017-06-19, under approval number K163029.

What company makes Hydris Oral Rinse?

Hydris Oral Rinse is manufactured by Biopharm Consult, LLC.

What is the FDA product code for Hydris Oral Rinse?

The FDA product code for Hydris Oral Rinse is LFD.

Related Devices (Code: LFD)

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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.