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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Implantable Pacemaker Pulse-Generator
510(k) Number K852688
Device Name MEDTRONICS MODELS 8320/8322/8329
Applicant
MEDTRONIC VASCULAR
800 53RD AVENUE, NE
P.O. BOX 1250
MINNEAPOLIS,  MN  55440 -9087
Applicant Contact TIMOTHY D SAMSEL
Correspondent
MEDTRONIC VASCULAR
800 53RD AVENUE, NE
P.O. BOX 1250
MINNEAPOLIS,  MN  55440 -9087
Correspondent Contact TIMOTHY D SAMSEL
Regulation Number870.3610
Classification Product Code
DXY  
Date Received06/25/1985
Decision Date 11/01/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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