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FDA 510(k)

Venturi Gauze Wound Care Sets with Portal Drain

K-Number: K151263 · 2016-02-19

Decision Date2016-02-19
Product CodeOMP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Venturi Gauze Wound Care Sets with Portal Drain is a medical device manufactured by Talley Group, Ltd.. It received FDA 510(k) clearance on 2016-02-19 under approval number K151263. 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 Venturi Gauze Wound Care Sets with Portal Drain?

Venturi Gauze Wound Care Sets with Portal Drain is a medical device that received FDA 510(k) clearance on 2016-02-19. It is manufactured by Talley Group, Ltd.. The 510(k) number is K151263.

When was Venturi Gauze Wound Care Sets with Portal Drain approved by the FDA?

Venturi Gauze Wound Care Sets with Portal Drain received FDA 510(k) clearance on 2016-02-19, under approval number K151263.

What company makes Venturi Gauze Wound Care Sets with Portal Drain?

Venturi Gauze Wound Care Sets with Portal Drain is manufactured by Talley Group, Ltd..

What is the FDA product code for Venturi Gauze Wound Care Sets with Portal Drain?

The FDA product code for Venturi Gauze Wound Care Sets with Portal Drain is OMP.

Related Clinical Trials

Other Devices by Talley Group, Ltd.

Related Devices (Code: OMP)

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.