FDA 510(k)

TruGuard Custom Tongue and Jaw Positioner

K-Number: K153270 · 2016-03-08

Decision Date2016-03-08

Product CodeIYE

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

TruGuard Custom Tongue and Jaw Positioner is a medical device manufactured by Bionix Development Corp.. It received FDA 510(k) clearance on 2016-03-08 under approval number K153270. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TruGuard Custom Tongue and Jaw Positioner?

TruGuard Custom Tongue and Jaw Positioner is a medical device that received FDA 510(k) clearance on 2016-03-08. It is manufactured by Bionix Development Corp.. The 510(k) number is K153270.

When was TruGuard Custom Tongue and Jaw Positioner approved by the FDA?

TruGuard Custom Tongue and Jaw Positioner received FDA 510(k) clearance on 2016-03-08, under approval number K153270.

What company makes TruGuard Custom Tongue and Jaw Positioner?

TruGuard Custom Tongue and Jaw Positioner is manufactured by Bionix Development Corp..

What is the FDA product code for TruGuard Custom Tongue and Jaw Positioner?

The FDA product code for TruGuard Custom Tongue and Jaw Positioner is IYE.

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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.