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FDA 510(k)

LM Surgical Mask Level 3, LM Surgical Mask Level 2,

K-Number: K211378 · 2021-12-16

ApplicantLiberty Mask, LLC
Decision Date2021-12-16
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LM Surgical Mask Level 3, LM Surgical Mask Level 2, is a medical device manufactured by Liberty Mask, LLC. It received FDA 510(k) clearance on 2021-12-16 under approval number K211378. 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 LM Surgical Mask Level 3, LM Surgical Mask Level 2,?

LM Surgical Mask Level 3, LM Surgical Mask Level 2, is a medical device that received FDA 510(k) clearance on 2021-12-16. It is manufactured by Liberty Mask, LLC. The 510(k) number is K211378.

When was LM Surgical Mask Level 3, LM Surgical Mask Level 2, approved by the FDA?

LM Surgical Mask Level 3, LM Surgical Mask Level 2, received FDA 510(k) clearance on 2021-12-16, under approval number K211378.

What company makes LM Surgical Mask Level 3, LM Surgical Mask Level 2,?

LM Surgical Mask Level 3, LM Surgical Mask Level 2, is manufactured by Liberty Mask, LLC.

What is the FDA product code for LM Surgical Mask Level 3, LM Surgical Mask Level 2,?

The FDA product code for LM Surgical Mask Level 3, LM Surgical Mask Level 2, is FXX.

Related Clinical Trials

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Related PubMed Literature

PMID: 42201559 Time-series and thematic analyses of clinical utilities and operational issues in early clinical studies of the da Vinci surgical system. Journal of robotic surgery (2026)

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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