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FDA 510(k)

Corrugated tube with mouthpiece accessory

K-Number: K203400 · 2021-06-14

Decision Date2021-06-14
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Corrugated tube with mouthpiece accessory is a medical device manufactured by Trudell Medical International. It received FDA 510(k) clearance on 2021-06-14 under approval number K203400. The device is classified under product code CAF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Corrugated tube with mouthpiece accessory?

Corrugated tube with mouthpiece accessory is a medical device that received FDA 510(k) clearance on 2021-06-14. It is manufactured by Trudell Medical International. The 510(k) number is K203400.

When was Corrugated tube with mouthpiece accessory approved by the FDA?

Corrugated tube with mouthpiece accessory received FDA 510(k) clearance on 2021-06-14, under approval number K203400.

What company makes Corrugated tube with mouthpiece accessory?

Corrugated tube with mouthpiece accessory is manufactured by Trudell Medical International.

What is the FDA product code for Corrugated tube with mouthpiece accessory?

The FDA product code for Corrugated tube with mouthpiece accessory is CAF.

Other Devices by Trudell Medical International

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Related Devices (Code: CAF)

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.