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FDA 510(k)

Protect U Guard Earloop and Tie-On Mask (Blue, White or Green)

K-Number: K153409 · 2016-11-15

ApplicantProtect U Guard, LLC
Decision Date2016-11-15
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Protect U Guard Earloop and Tie-On Mask (Blue, White or Green) is a medical device manufactured by Protect U Guard, LLC. It received FDA 510(k) clearance on 2016-11-15 under approval number K153409. The device is classified under product code FXX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Protect U Guard Earloop and Tie-On Mask (Blue, White or Green)?

Protect U Guard Earloop and Tie-On Mask (Blue, White or Green) is a medical device that received FDA 510(k) clearance on 2016-11-15. It is manufactured by Protect U Guard, LLC. The 510(k) number is K153409.

When was Protect U Guard Earloop and Tie-On Mask (Blue, White or Green) approved by the FDA?

Protect U Guard Earloop and Tie-On Mask (Blue, White or Green) received FDA 510(k) clearance on 2016-11-15, under approval number K153409.

What company makes Protect U Guard Earloop and Tie-On Mask (Blue, White or Green)?

Protect U Guard Earloop and Tie-On Mask (Blue, White or Green) is manufactured by Protect U Guard, LLC.

What is the FDA product code for Protect U Guard Earloop and Tie-On Mask (Blue, White or Green)?

The FDA product code for Protect U Guard Earloop and Tie-On Mask (Blue, White or Green) is FXX.

Related Clinical Trials

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Related Devices (Code: FXX)

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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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