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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 K013392
Device Name CARDIOBLATE SURGICAL ABLATION PEN, MODEL 60811C; CARDIOBLATE SURGICAL ABLATION GENERATOR, MODEL 60880
Applicant
Medtronic Vascular
1015 Gramsie Rd.
Shoreview,  MN  55126 -3082
Applicant Contact SCOTT CANDY
Correspondent
Medtronic Vascular
1015 Gramsie Rd.
Shoreview,  MN  55126 -3082
Correspondent Contact SCOTT CANDY
Regulation Number878.4400
Classification Product Code
OCL  
Date Received10/15/2001
Decision Date 01/25/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Cardiovascular
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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