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FDA 510(k)

IFM Surgical Mask Model SM3

K-Number: K202214 · 2021-03-02

ApplicantFssc, LLC
Decision Date2021-03-02
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

IFM Surgical Mask Model SM3 is a medical device manufactured by Fssc, LLC. It received FDA 510(k) clearance on 2021-03-02 under approval number K202214. 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 IFM Surgical Mask Model SM3?

IFM Surgical Mask Model SM3 is a medical device that received FDA 510(k) clearance on 2021-03-02. It is manufactured by Fssc, LLC. The 510(k) number is K202214.

When was IFM Surgical Mask Model SM3 approved by the FDA?

IFM Surgical Mask Model SM3 received FDA 510(k) clearance on 2021-03-02, under approval number K202214.

What company makes IFM Surgical Mask Model SM3?

IFM Surgical Mask Model SM3 is manufactured by Fssc, LLC.

What is the FDA product code for IFM Surgical Mask Model SM3?

The FDA product code for IFM Surgical Mask Model SM3 is FXX.

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Related PubMed Literature

PMID: 25646114 Transcatheter valve therapy registry is a model for medical device innovation and surveillance. Health affairs (Project Hope) (2015)

Related Devices (Code: 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.

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