Spin Care Disposable Protective Mask Level 3
K-Number: K212109 · 2021-11-14
ApplicantSpintech, LLC
Decision Date2021-11-14
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Spin Care Disposable Protective Mask Level 3 is a medical device manufactured by Spintech, LLC. It received FDA 510(k) clearance on 2021-11-14 under approval number K212109. 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 Spin Care Disposable Protective Mask Level 3?
Spin Care Disposable Protective Mask Level 3 is a medical device that received FDA 510(k) clearance on 2021-11-14. It is manufactured by Spintech, LLC. The 510(k) number is K212109.
When was Spin Care Disposable Protective Mask Level 3 approved by the FDA?
Spin Care Disposable Protective Mask Level 3 received FDA 510(k) clearance on 2021-11-14, under approval number K212109.
What company makes Spin Care Disposable Protective Mask Level 3?
Spin Care Disposable Protective Mask Level 3 is manufactured by Spintech, LLC.
What is the FDA product code for Spin Care Disposable Protective Mask Level 3?
The FDA product code for Spin Care Disposable Protective Mask Level 3 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.