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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 K810677
Device Name MODELS 5976/5977 PACEMAKER PULSE GENER
Applicant
Medtronic, Inc.
Mounds View,  MN  55112
Applicant Contact Rachel Brucker
Correspondent
Medtronic Vascular
Mounds View,  MN  55112
Correspondent Contact RACHEL BRUCKER
Regulation Number870.3610
Classification Product Code
DXY  
Date Received03/13/1981
Decision Date 05/27/1981
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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