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FDA 510(k)

Disposable Medical Face Mask (DF3-001)

K-Number: K222697 · 2022-11-04

ApplicantWellmed Dental Medical Supply Co., Ltd.
Decision Date2022-11-04
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Disposable Medical Face Mask (DF3-001) is a medical device manufactured by Wellmed Dental Medical Supply Co., Ltd.. It received FDA 510(k) clearance on 2022-11-04 under approval number K222697. 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 Disposable Medical Face Mask (DF3-001)?

Disposable Medical Face Mask (DF3-001) is a medical device that received FDA 510(k) clearance on 2022-11-04. It is manufactured by Wellmed Dental Medical Supply Co., Ltd.. The 510(k) number is K222697.

When was Disposable Medical Face Mask (DF3-001) approved by the FDA?

Disposable Medical Face Mask (DF3-001) received FDA 510(k) clearance on 2022-11-04, under approval number K222697.

What company makes Disposable Medical Face Mask (DF3-001)?

Disposable Medical Face Mask (DF3-001) is manufactured by Wellmed Dental Medical Supply Co., Ltd..

What is the FDA product code for Disposable Medical Face Mask (DF3-001)?

The FDA product code for Disposable Medical Face Mask (DF3-001) is FXX.

Related Clinical Trials

NCT07273877 "Real-world Assessment of BP Control in Patients With Hypertension by the Netrod RDN System" - REACH-RDN ENROLLING_BY_INVITATION

Other Devices by Wellmed Dental Medical Supply Co., Ltd.

K242435Dental Barrier and Sleeves K243721Self Sealing Sterilization Pouches

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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