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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 K230547
Device Name PlumePen Elite Surgical Smoke Evacuation Pencils, PlumePen Pro Surgical Smoke Evacuation Pencil, PlumePen Ultra Surgical Smoke Evacuation Pencils, PenAdapt Electrosurgical Pencil Adapter, SnapEvac Electrosurgical Pencil Adapter
Applicant
ConMed Corporation
525 French Road
Utica,  NY  13502
Applicant Contact Ali AbuSaleh
Correspondent
ConMed Corporation
525 French Road
Utica,  NY  13502
Correspondent Contact Ali AbuSaleh
Regulation Number878.4400
Classification Product Code
GEI  
Subsequent Product Code
FYD  
Date Received02/28/2023
Decision Date 04/27/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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