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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 the device name listed in this FDA 510(k) record. The listed applicant is Medline Industires, Inc.. It received FDA 510(k) clearance on 2020-10-16 under 510(k) 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. The listed applicant is Medline Industires, Inc.. The 510(k) number is K201129.

When did Medline Smoke Evacuation Pencil receive FDA 510(k) clearance?

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

Who is the listed applicant for Medline Smoke Evacuation Pencil?

The FDA 510(k) record lists Medline Industires, Inc. as the applicant. This does not by itself establish the device manufacturer.

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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