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FDA 510(k)

Medline Smoke Evacuation Shroud

K-Number: K213068 · 2022-01-03

Decision Date2022-01-03
Product CodeFYD
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Medline Smoke Evacuation Shroud is a medical device manufactured by Medline Industries, Inc.. It received FDA 510(k) clearance on 2022-01-03 under approval number K213068. The device is classified under product code FYD. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Medline Smoke Evacuation Shroud?

Medline Smoke Evacuation Shroud is a medical device that received FDA 510(k) clearance on 2022-01-03. It is manufactured by Medline Industries, Inc.. The 510(k) number is K213068.

When was Medline Smoke Evacuation Shroud approved by the FDA?

Medline Smoke Evacuation Shroud received FDA 510(k) clearance on 2022-01-03, under approval number K213068.

What company makes Medline Smoke Evacuation Shroud?

Medline Smoke Evacuation Shroud is manufactured by Medline Industries, Inc..

What is the FDA product code for Medline Smoke Evacuation Shroud?

The FDA product code for Medline Smoke Evacuation Shroud is FYD.

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Official Source

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