FDA 510(k)

PM Excellence SEQUR 100 Surgical Face Mask

K-Number: K220520 · 2022-12-15

Decision Date2022-12-15

Product CodeFXX

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

PM Excellence SEQUR 100 Surgical Face Mask is a medical device manufactured by Pm Excellence, LLC. It received FDA 510(k) clearance on 2022-12-15 under approval number K220520. 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 PM Excellence SEQUR 100 Surgical Face Mask?

PM Excellence SEQUR 100 Surgical Face Mask is a medical device that received FDA 510(k) clearance on 2022-12-15. It is manufactured by Pm Excellence, LLC. The 510(k) number is K220520.

When was PM Excellence SEQUR 100 Surgical Face Mask approved by the FDA?

PM Excellence SEQUR 100 Surgical Face Mask received FDA 510(k) clearance on 2022-12-15, under approval number K220520.

What company makes PM Excellence SEQUR 100 Surgical Face Mask?

PM Excellence SEQUR 100 Surgical Face Mask is manufactured by Pm Excellence, LLC.

What is the FDA product code for PM Excellence SEQUR 100 Surgical Face Mask?

The FDA product code for PM Excellence SEQUR 100 Surgical Face Mask is FXX.

Related Devices (Code: FXX)

K153409Protect U Guard Earloop and Tie-On Mask (Blue, White or Green)Protect U Guard, LLC K160269Surgical Face Masks (Ear loops and Tie-on)San-M Package Co., Ltd. K152197Skypro, SP01 MaskSkypro Medical Supplies Company K153496Disposable Surgical Face MaskXiantao Rayxin Medical Products Co., Ltd. K152561Communicator Surgical Facemask with Clear WindowPrestige Ameritech , Ltd. K171162Surgical Earloop Face Mask with Bottom Gap Shield and Surgical Tie-On Face Mask with Bottom Gap ShieldPrestige Ameritech

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.