Disposable Face Mask
K-Number: K210815 · 2021-05-13
Decision Date2021-05-13
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Disposable Face Mask is a medical device manufactured by Biobase Scientific (Shandong) Co., Ltd.. It received FDA 510(k) clearance on 2021-05-13 under approval number K210815. 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 Face Mask?
Disposable Face Mask is a medical device that received FDA 510(k) clearance on 2021-05-13. It is manufactured by Biobase Scientific (Shandong) Co., Ltd.. The 510(k) number is K210815.
When was Disposable Face Mask approved by the FDA?
Disposable Face Mask received FDA 510(k) clearance on 2021-05-13, under approval number K210815.
What company makes Disposable Face Mask?
Disposable Face Mask is manufactured by Biobase Scientific (Shandong) Co., Ltd..
What is the FDA product code for Disposable Face Mask?
The FDA product code for Disposable 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.