FDA 510(k)

Surgical Mask

K-Number: K203425 · 2021-03-05

Decision Date2021-03-05

Product CodeFXX

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Surgical Mask is a medical device manufactured by Bdc Dental Corporation , Ltd.. It received FDA 510(k) clearance on 2021-03-05 under approval number K203425. 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 2021-03-05. It is manufactured by Bdc Dental Corporation , Ltd.. The 510(k) number is K203425.

When was Surgical Mask approved by the FDA?

Surgical Mask received FDA 510(k) clearance on 2021-03-05, under approval number K203425.

What company makes Surgical Mask?

Surgical Mask is manufactured by Bdc Dental Corporation , Ltd..

What is the FDA product code for Surgical Mask?

The FDA product code for Surgical Mask is FXX.

Other Devices by Bdc Dental Corporation , Ltd.

K242404BDC Dental Unit

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.