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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 K853425
Device Name CARIO-PACE DURAPULSE P101 COATED PULSE GENERATOR
Applicant
Cardio-Pace Medical, Inc.
2833 N. Fairview Ave.
St. Paul,  MN  55113
Applicant Contact RONALD J GMYREK
Correspondent
Cardio-Pace Medical, Inc.
2833 N. Fairview Ave.
St. Paul,  MN  55113
Correspondent Contact RONALD J GMYREK
Regulation Number870.3610
Classification Product Code
DXY  
Date Received08/14/1985
Decision Date 08/19/1985
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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