Topwide Surgical Face Mask
K-Number: K210102 · 2021-12-17
Decision Date2021-12-17
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Topwide Surgical Face Mask is a medical device manufactured by Topwide (Hubei) Medical Products Manufacturer. It received FDA 510(k) clearance on 2021-12-17 under approval number K210102. 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 Topwide Surgical Face Mask?
Topwide Surgical Face Mask is a medical device that received FDA 510(k) clearance on 2021-12-17. It is manufactured by Topwide (Hubei) Medical Products Manufacturer. The 510(k) number is K210102.
When was Topwide Surgical Face Mask approved by the FDA?
Topwide Surgical Face Mask received FDA 510(k) clearance on 2021-12-17, under approval number K210102.
What company makes Topwide Surgical Face Mask?
Topwide Surgical Face Mask is manufactured by Topwide (Hubei) Medical Products Manufacturer.
What is the FDA product code for Topwide Surgical Face Mask?
The FDA product code for Topwide Surgical 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.