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FDA 510(k)

Single-use Surgical Mask

K-Number: K200923 · 2020-08-26

ApplicantByd Precision Manufacturer Co., Ltd.
Decision Date2020-08-26
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Single-use Surgical Mask is a medical device manufactured by Byd Precision Manufacturer Co., Ltd.. It received FDA 510(k) clearance on 2020-08-26 under approval number K200923. 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 Single-use Surgical Mask?

Single-use Surgical Mask is a medical device that received FDA 510(k) clearance on 2020-08-26. It is manufactured by Byd Precision Manufacturer Co., Ltd.. The 510(k) number is K200923.

When was Single-use Surgical Mask approved by the FDA?

Single-use Surgical Mask received FDA 510(k) clearance on 2020-08-26, under approval number K200923.

What company makes Single-use Surgical Mask?

Single-use Surgical Mask is manufactured by Byd Precision Manufacturer Co., Ltd..

What is the FDA product code for Single-use Surgical Mask?

The FDA product code for Single-use Surgical 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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