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FDA 510(k)

Modified Novy Cornual Cannulation Set

K-Number: K180552 · 2018-07-12

Decision Date2018-07-12
Product CodeMOV
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Modified Novy Cornual Cannulation Set is the device name listed in this FDA 510(k) record. The listed applicant is Cook Incorporated. It received FDA 510(k) clearance on 2018-07-12 under 510(k) number K180552. The device is classified under product code MOV. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Modified Novy Cornual Cannulation Set?

Modified Novy Cornual Cannulation Set is a medical device that received FDA 510(k) clearance on 2018-07-12. The listed applicant is Cook Incorporated. The 510(k) number is K180552.

When did Modified Novy Cornual Cannulation Set receive FDA 510(k) clearance?

Modified Novy Cornual Cannulation Set received FDA 510(k) clearance on 2018-07-12, under 510(k) number K180552.

Who is the listed applicant for Modified Novy Cornual Cannulation Set?

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

What is the FDA product code for Modified Novy Cornual Cannulation Set?

The FDA product code for Modified Novy Cornual Cannulation Set is MOV.

Other records listing Cook Incorporated as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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