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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 K210338
Device Name Edge Insulated Blade Electrode
Applicant
Covidien LLC
5920 Longbow Drive
Boulder,  CO  80301
Applicant Contact Miranda Miles
Correspondent
Covidien LLC
5920 Longbow Drive
Boulder,  CO  80301
Correspondent Contact Miranda Miles
Regulation Number878.4400
Classification Product Code
GEI  
Date Received02/05/2021
Decision Date 04/15/2021
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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