FDA 510(k)

SiO2 Coated syringe 3 ml

Numéro K : K153553 · 2016-05-17

Date de décision2016-05-17

Code produitFMF

Comité consultatifHO

DécisionSubstantially Equivalent

Résumé du dispositif

SiO2 Coated syringe 3 ml is the device name listed in this FDA 510(k) record. The listed applicant is Sio2 Medical Products. It received FDA 510(k) clearance on 2016-05-17 under 510(k) number K153553. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the SiO2 Coated syringe 3 ml?

SiO2 Coated syringe 3 ml is a medical device that received FDA 510(k) clearance on 2016-05-17. The listed applicant is Sio2 Medical Products. The 510(k) number is K153553.

When did SiO2 Coated syringe 3 ml receive FDA 510(k) clearance?

SiO2 Coated syringe 3 ml received FDA 510(k) clearance on 2016-05-17, under 510(k) number K153553.

Who is the listed applicant for SiO2 Coated syringe 3 ml?

The FDA 510(k) record lists Sio2 Medical Products as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SiO2 Coated syringe 3 ml?

The FDA product code for SiO2 Coated syringe 3 ml is FMF.

Essais cliniques associés

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Dispositifs connexes (Code : FMF)

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Source officielle

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