FDA 510(k)

Bodygard SFS Surgical Gown Level 4

Numéro K : K221139 · 2022-11-10

DemandeurFeliks Plastik Laminasyon VE Ambalaj Malzemeleri

Date de décision2022-11-10

Code produitFYA

Comité consultatifSU

DécisionSubstantially Equivalent

Résumé du dispositif

Bodygard SFS Surgical Gown Level 4 is the device name listed in this FDA 510(k) record. The listed applicant is Feliks Plastik Laminasyon VE Ambalaj Malzemeleri. It received FDA 510(k) clearance on 2022-11-10 under 510(k) number K221139. The device is classified under product code FYA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Bodygard SFS Surgical Gown Level 4?

Bodygard SFS Surgical Gown Level 4 is a medical device that received FDA 510(k) clearance on 2022-11-10. The listed applicant is Feliks Plastik Laminasyon VE Ambalaj Malzemeleri. The 510(k) number is K221139.

When did Bodygard SFS Surgical Gown Level 4 receive FDA 510(k) clearance?

Bodygard SFS Surgical Gown Level 4 received FDA 510(k) clearance on 2022-11-10, under 510(k) number K221139.

Who is the listed applicant for Bodygard SFS Surgical Gown Level 4?

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

What is the FDA product code for Bodygard SFS Surgical Gown Level 4?

The FDA product code for Bodygard SFS Surgical Gown Level 4 is FYA.

Essais cliniques associés

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Dispositifs connexes (Code : FYA)

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Source officielle

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