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FDA 510(k)

Cook 810 Set, Desilets-Hoffman Introducer Set

K-Number: K180028 · 2018-05-02

ApplicantCook Incorporated
Decision Date2018-05-02
Product CodeEZN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Cook 810 Set, Desilets-Hoffman Introducer Set is a medical device manufactured by Cook Incorporated. It received FDA 510(k) clearance on 2018-05-02 under approval number K180028. The device is classified under product code EZN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Cook 810 Set, Desilets-Hoffman Introducer Set?

Cook 810 Set, Desilets-Hoffman Introducer Set is a medical device that received FDA 510(k) clearance on 2018-05-02. It is manufactured by Cook Incorporated. The 510(k) number is K180028.

When was Cook 810 Set, Desilets-Hoffman Introducer Set approved by the FDA?

Cook 810 Set, Desilets-Hoffman Introducer Set received FDA 510(k) clearance on 2018-05-02, under approval number K180028.

What company makes Cook 810 Set, Desilets-Hoffman Introducer Set?

Cook 810 Set, Desilets-Hoffman Introducer Set is manufactured by Cook Incorporated.

What is the FDA product code for Cook 810 Set, Desilets-Hoffman Introducer Set?

The FDA product code for Cook 810 Set, Desilets-Hoffman Introducer Set is EZN.

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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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