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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 K070288
Device Name CARDIOBLATE MONOPOLAR PEN, 60813, CARDIOBLATE MONOPOLAR XL, 60814
Applicant
MEDTRONIC VASCULAR
7601 NORTHLAND DRIVE
MINNEAPOLIS,  MN  55428
Applicant Contact SCOTT CUNDY
Correspondent
MEDTRONIC VASCULAR
7601 NORTHLAND DRIVE
MINNEAPOLIS,  MN  55428
Correspondent Contact SCOTT CUNDY
Regulation Number878.4400
Classification Product Code
OCL  
Date Received01/30/2007
Decision Date 06/18/2007
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
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