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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue
510(k) Number K200514
Device Name Cardioblate Gemini-s Surgical Ablation Device
Applicant
Medtronic
7611 Northland Dr.
Minneapolis,  MN  55428
Applicant Contact Rahul Shah
Correspondent
Medtronic
7611 Northland Dr.
Minneapolis,  MN  55428
Correspondent Contact Rahul Shah
Regulation Number878.4400
Classification Product Code
OCL  
Date Received03/02/2020
Decision Date 06/03/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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