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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instruments, Surgical, Cardiovascular
510(k) Number K022238
Device Name MYOCARDIAL LEAD IMPLANT TOOL, MODEL 10626
Applicant
Medtronic Vascular
7000 Central Ave. NE
Ms Cw 304
Minneapolis,  MN  55432 -3576
Applicant Contact MARY ELLEN BEST
Correspondent
Medtronic Vascular
7000 Central Ave. NE
Ms Cw 304
Minneapolis,  MN  55432 -3576
Correspondent Contact MARY ELLEN BEST
Regulation Number870.4500
Classification Product Code
DWS  
Date Received07/11/2002
Decision Date 10/09/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
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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