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FDA 510(k)

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

K-Number: K180868 · 2018-07-06

ApplicantCook Ireland
Decision Date2018-07-06
Product CodeFGE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

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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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