FDA 510(k)

Kits de pansements en mousse avec FitPad, Kits de pansements en mousse avec FitPad, Kits de pansements en gaze avec FitPad, FitPad Invia, Film transparent Invia

Numéro K : K170088 · 2017-04-06

Date de décision2017-04-06

Code produitOMP

Comité consultatifSU

DécisionSubstantially Equivalent

Résumé du dispositif

Invia Foam Dressing Kits with FitPad, Invia Foam Dressing Kits with FitPad, Invia Gauze Dressing Kits with FitPad, Invia FitPad, Invia Transparent Film is the device name listed in this FDA 510(k) record. The listed applicant is Medela AG. It received FDA 510(k) clearance on 2017-04-06 under 510(k) number K170088. The device is classified under product code OMP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Invia Foam Dressing Kits with FitPad, Invia Foam Dressing Kits with FitPad, Invia Gauze Dressing Kits with FitPad, Invia FitPad, Invia Transparent Film?

Invia Foam Dressing Kits with FitPad, Invia Foam Dressing Kits with FitPad, Invia Gauze Dressing Kits with FitPad, Invia FitPad, Invia Transparent Film is a medical device that received FDA 510(k) clearance on 2017-04-06. The listed applicant is Medela AG. The 510(k) number is K170088.

When did Invia Foam Dressing Kits with FitPad, Invia Foam Dressing Kits with FitPad, Invia Gauze Dressing Kits with FitPad, Invia FitPad, Invia Transparent Film receive FDA 510(k) clearance?

Invia Foam Dressing Kits with FitPad, Invia Foam Dressing Kits with FitPad, Invia Gauze Dressing Kits with FitPad, Invia FitPad, Invia Transparent Film received FDA 510(k) clearance on 2017-04-06, under 510(k) number K170088.

Who is the listed applicant for Invia Foam Dressing Kits with FitPad, Invia Foam Dressing Kits with FitPad, Invia Gauze Dressing Kits with FitPad, Invia FitPad, Invia Transparent Film?

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

What is the FDA product code for Invia Foam Dressing Kits with FitPad, Invia Foam Dressing Kits with FitPad, Invia Gauze Dressing Kits with FitPad, Invia FitPad, Invia Transparent Film?

The FDA product code for Invia Foam Dressing Kits with FitPad, Invia Foam Dressing Kits with FitPad, Invia Gauze Dressing Kits with FitPad, Invia FitPad, Invia Transparent Film is OMP.

Essais cliniques associés

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Autres dossiers indiquant Medela AG en tant que demandeur

K251377Magic InBra K223388Invia® Pansement Intégré K214112Invia Ease Système de Thérapie de Pression Negative de Wound (NPWT)K191653Freestyle Flex K182191Kit de pansement abdominal Invia K180415Invia White Foam NPWT

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Source officielle

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