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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 K870142
Device Name PINNACLE SR 8701 - UNIPOLAR & 8702 - BIPOLAR
Applicant
Cardio-Pace Medical, Inc.
8990 Springbrook Dr.
Suite 100
Minneapolis,  MN  55433
Applicant Contact DAVID P LANG
Correspondent
Cardio-Pace Medical, Inc.
8990 Springbrook Dr.
Suite 100
Minneapolis,  MN  55433
Correspondent Contact DAVID P LANG
Regulation Number870.3610
Classification Product Code
DXY  
Date Received01/13/1987
Decision Date 04/22/1987
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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