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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 K812832
Device Name MODEL 325C UNIPOLAR CARDIAC PULSE GEN.
Applicant
COOK PACEMAKER CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
COOK PACEMAKER CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number870.3610
Classification Product Code
DXY  
Date Received10/09/1981
Decision Date 11/05/1981
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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