Freudenberg Surgical Mask
K-Number: K210063 · 2021-02-05
ApplicantFreudenberg Performance Materials LP
Decision Date2021-02-05
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Freudenberg Surgical Mask is a medical device manufactured by Freudenberg Performance Materials LP. It received FDA 510(k) clearance on 2021-02-05 under approval number K210063. 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 Freudenberg Surgical Mask?
Freudenberg Surgical Mask is a medical device that received FDA 510(k) clearance on 2021-02-05. It is manufactured by Freudenberg Performance Materials LP. The 510(k) number is K210063.
When was Freudenberg Surgical Mask approved by the FDA?
Freudenberg Surgical Mask received FDA 510(k) clearance on 2021-02-05, under approval number K210063.
What company makes Freudenberg Surgical Mask?
Freudenberg Surgical Mask is manufactured by Freudenberg Performance Materials LP.
What is the FDA product code for Freudenberg Surgical Mask?
The FDA product code for Freudenberg 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.