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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 a medical device manufactured by Feliks Plastik Laminasyon VE Ambalaj Malzemeleri Sanayi. It received FDA 510(k) clearance on 2022-01-23 under approval 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. It is manufactured by Feliks Plastik Laminasyon VE Ambalaj Malzemeleri Sanayi. The 510(k) number is K212111.

When was Myflon Surgical Mask Level 3 approved by the FDA?

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

What company makes Myflon Surgical Mask Level 3?

Myflon Surgical Mask Level 3 is manufactured by Feliks Plastik Laminasyon VE Ambalaj Malzemeleri Sanayi.

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

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

Related Clinical Trials

NCT07609888 Photodynamic Therapy as an Adjunct to Non-Surgical Periodontal Therapy in Stage II Periodontitis: A Randomized Split-Mouth Study COMPLETED NCT07489820 Evaluation of the Efficacy of Negative Pressure Wound Therapy on Perineal Healing Following Abdominoperineal Amputation NOT_YET_RECRUITING NCT02747485 Impact of Diffuse Myocardial Fibrosis on the Ventricular Function in Regurgitant Left-Sided Valve Heart Diseases ( The DIFFUsE Study) ACTIVE_NOT_RECRUITING NCT04859725 HyperSpectral Imaging in Low Grade Glioma ACTIVE_NOT_RECRUITING NCT07580664 Long-term Assessment of BDyn Dynamic Stabilization Device in Patients With Lumbar Degenerative Disc Disease NOT_YET_RECRUITING NCT07524712 Effects of Energy Versus Mechanical Surgical Devices on Postoperative Cough NOT_YET_RECRUITING

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)

Other Devices by Feliks Plastik Laminasyon VE Ambalaj Malzemeleri Sanayi

K202845Bodygard SFS Surgical Gown Level 3

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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