FDA 510(k)

Nasal Biliary Drainage Set, Liguory Nasal Biliary Drainage Set, Nagaraja Nasal Biliary Drainage Set, Leung Nasal Biliary Drainage Set

Numéro K : K180868 · 2018-07-06

Date de décision2018-07-06

Code produitFGE

Comité consultatifGU

DécisionSubstantially Equivalent

Résumé du dispositif

Nasal Biliary Drainage Set, Liguory Nasal Biliary Drainage Set, Nagaraja Nasal Biliary Drainage Set, Leung Nasal Biliary Drainage Set is the device name listed in this FDA 510(k) record. The listed applicant is Cook Ireland. It received FDA 510(k) clearance on 2018-07-06 under 510(k) number K180868. The device is classified under product code FGE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Nasal Biliary Drainage Set, Liguory Nasal Biliary Drainage Set, Nagaraja Nasal Biliary Drainage Set, Leung Nasal Biliary Drainage Set?

Nasal Biliary Drainage Set, Liguory Nasal Biliary Drainage Set, Nagaraja Nasal Biliary Drainage Set, Leung Nasal Biliary Drainage Set is a medical device that received FDA 510(k) clearance on 2018-07-06. The listed applicant is Cook Ireland. The 510(k) number is K180868.

When did Nasal Biliary Drainage Set, Liguory Nasal Biliary Drainage Set, Nagaraja Nasal Biliary Drainage Set, Leung Nasal Biliary Drainage Set receive FDA 510(k) clearance?

Nasal Biliary Drainage Set, Liguory Nasal Biliary Drainage Set, Nagaraja Nasal Biliary Drainage Set, Leung Nasal Biliary Drainage Set received FDA 510(k) clearance on 2018-07-06, under 510(k) number K180868.

Who is the listed applicant for Nasal Biliary Drainage Set, Liguory Nasal Biliary Drainage Set, Nagaraja Nasal Biliary Drainage Set, Leung Nasal Biliary Drainage Set?

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

What is the FDA product code for Nasal Biliary Drainage Set, Liguory Nasal Biliary Drainage Set, Nagaraja Nasal Biliary Drainage Set, Leung Nasal Biliary Drainage Set?

The FDA product code for Nasal Biliary Drainage Set, Liguory Nasal Biliary Drainage Set, Nagaraja Nasal Biliary Drainage Set, Leung Nasal Biliary Drainage Set is FGE.

Essais cliniques associés

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Dispositifs connexes (Code : FGE)

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Source officielle

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