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FDA 510(k)

Myflon Surgical Mask Level 3

K-Number: K212111 · 2022-01-23

ApplicantFeliks Plastik Laminasyon VE Ambalaj Malzemeleri Sanayi
Decision Date2022-01-23
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Myflon Surgical Mask Level 3 is the device name listed in this FDA 510(k) record. The listed applicant is Feliks Plastik Laminasyon VE Ambalaj Malzemeleri Sanayi. It received FDA 510(k) clearance on 2022-01-23 under 510(k) number K212111. 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 Myflon Surgical Mask Level 3?

Myflon Surgical Mask Level 3 is a medical device that received FDA 510(k) clearance on 2022-01-23. The listed applicant is Feliks Plastik Laminasyon VE Ambalaj Malzemeleri Sanayi. The 510(k) number is K212111.

When did Myflon Surgical Mask Level 3 receive FDA 510(k) clearance?

Myflon Surgical Mask Level 3 received FDA 510(k) clearance on 2022-01-23, under 510(k) number K212111.

Who is the listed applicant for Myflon Surgical Mask Level 3?

The FDA 510(k) record lists Feliks Plastik Laminasyon VE Ambalaj Malzemeleri Sanayi as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Myflon Surgical Mask Level 3?

The FDA product code for Myflon Surgical Mask Level 3 is FXX.

Other records listing Feliks Plastik Laminasyon VE Ambalaj Malzemeleri Sanayi as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K202845Bodygard SFS Surgical Gown Level 3

Related Devices (Code: FXX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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