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FDA 510(k)

Occlusion Detection Dressing Kit

K-Number: K171499 · 2017-09-22

Decision Date2017-09-22
Product CodeOMP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Occlusion Detection Dressing Kit is a medical device manufactured by Cardinalhealth. It received FDA 510(k) clearance on 2017-09-22 under approval number K171499. The device is classified under product code OMP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Occlusion Detection Dressing Kit?

Occlusion Detection Dressing Kit is a medical device that received FDA 510(k) clearance on 2017-09-22. It is manufactured by Cardinalhealth. The 510(k) number is K171499.

When was Occlusion Detection Dressing Kit approved by the FDA?

Occlusion Detection Dressing Kit received FDA 510(k) clearance on 2017-09-22, under approval number K171499.

What company makes Occlusion Detection Dressing Kit?

Occlusion Detection Dressing Kit is manufactured by Cardinalhealth.

What is the FDA product code for Occlusion Detection Dressing Kit?

The FDA product code for Occlusion Detection Dressing Kit is OMP.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.