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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name electrosurgical, cutting & coagulation & accessories
510(k) Number K201129
Device Name Medline Smoke Evacuation Pencil
Applicant
Medline Industires, Inc.
Three Lakes Drive
Northfield,  IL  60093
Applicant Contact Matt Clausen
Correspondent
Medline Industires, Inc.
Three Lakes Drive
Northfield,  IL  60093
Correspondent Contact Matt Clausen
Regulation Number878.4400
Classification Product Code
GEI  
Date Received04/28/2020
Decision Date 10/16/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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