Sovereign America Surgical Face Mask
K-Number: K201095 · 2021-03-19
ApplicantHomtex, Inc.
Decision Date2021-03-19
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Sovereign America Surgical Face Mask is a medical device manufactured by Homtex, Inc.. It received FDA 510(k) clearance on 2021-03-19 under approval number K201095. 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 Sovereign America Surgical Face Mask?
Sovereign America Surgical Face Mask is a medical device that received FDA 510(k) clearance on 2021-03-19. It is manufactured by Homtex, Inc.. The 510(k) number is K201095.
When was Sovereign America Surgical Face Mask approved by the FDA?
Sovereign America Surgical Face Mask received FDA 510(k) clearance on 2021-03-19, under approval number K201095.
What company makes Sovereign America Surgical Face Mask?
Sovereign America Surgical Face Mask is manufactured by Homtex, Inc..
What is the FDA product code for Sovereign America Surgical Face Mask?
The FDA product code for Sovereign America 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.