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FDA 510(k)

Medline Smoke Evacuation Pencil

K-Number: K201129 · 2020-10-16

ApplicantMedline Industires, Inc.
Decision Date2020-10-16
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Medline Smoke Evacuation Pencil is a medical device manufactured by Medline Industires, Inc.. It received FDA 510(k) clearance on 2020-10-16 under approval number K201129. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Medline Smoke Evacuation Pencil?

Medline Smoke Evacuation Pencil is a medical device that received FDA 510(k) clearance on 2020-10-16. It is manufactured by Medline Industires, Inc.. The 510(k) number is K201129.

When was Medline Smoke Evacuation Pencil approved by the FDA?

Medline Smoke Evacuation Pencil received FDA 510(k) clearance on 2020-10-16, under approval number K201129.

What company makes Medline Smoke Evacuation Pencil?

Medline Smoke Evacuation Pencil is manufactured by Medline Industires, Inc..

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

The FDA product code for Medline Smoke Evacuation Pencil is GEI.

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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.

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