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FDA 510(k)

Disposable Procedural Ear-loop Face Mask

K-Number: K211042 · 2021-07-15

ApplicantChangzhou Dsb Medical Co., Ltd.
Decision Date2021-07-15
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Disposable Procedural Ear-loop Face Mask is a medical device manufactured by Changzhou Dsb Medical Co., Ltd.. It received FDA 510(k) clearance on 2021-07-15 under approval number K211042. 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 Procedural Ear-loop Face Mask?

Disposable Procedural Ear-loop Face Mask is a medical device that received FDA 510(k) clearance on 2021-07-15. It is manufactured by Changzhou Dsb Medical Co., Ltd.. The 510(k) number is K211042.

When was Disposable Procedural Ear-loop Face Mask approved by the FDA?

Disposable Procedural Ear-loop Face Mask received FDA 510(k) clearance on 2021-07-15, under approval number K211042.

What company makes Disposable Procedural Ear-loop Face Mask?

Disposable Procedural Ear-loop Face Mask is manufactured by Changzhou Dsb Medical Co., Ltd..

What is the FDA product code for Disposable Procedural Ear-loop Face Mask?

The FDA product code for Disposable Procedural Ear-loop Face Mask is 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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