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FDA 510(k)

Surgical Mask

K-Number: K203012 · 2021-04-11

ApplicantCustomfab, Inc.
Decision Date2021-04-11
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Surgical Mask is a medical device manufactured by Customfab, Inc.. It received FDA 510(k) clearance on 2021-04-11 under approval number K203012. 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 Surgical Mask?

Surgical Mask is a medical device that received FDA 510(k) clearance on 2021-04-11. It is manufactured by Customfab, Inc.. The 510(k) number is K203012.

When was Surgical Mask approved by the FDA?

Surgical Mask received FDA 510(k) clearance on 2021-04-11, under approval number K203012.

What company makes Surgical Mask?

Surgical Mask is manufactured by Customfab, Inc..

What is the FDA product code for Surgical Mask?

The FDA product code for Surgical 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

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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