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FDA 510(k)

Single-use Surgical Mask

K-Number: K211773 · 2021-12-02

ApplicantTaiwan Seafood and Fish Corporation
Decision Date2021-12-02
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Single-use Surgical Mask is a medical device manufactured by Taiwan Seafood and Fish Corporation. It received FDA 510(k) clearance on 2021-12-02 under approval number K211773. 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 2021-12-02. It is manufactured by Taiwan Seafood and Fish Corporation. The 510(k) number is K211773.

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

Single-use Surgical Mask received FDA 510(k) clearance on 2021-12-02, under approval number K211773.

What company makes Single-use Surgical Mask?

Single-use Surgical Mask is manufactured by Taiwan Seafood and Fish Corporation.

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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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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