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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 K832893
Device Name MODEL 329T PROGRAMMABLE, BIPOLAR CARDI
Applicant
COOK PACEMAKER CORP.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
COOK PACEMAKER CORP.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number870.3610
Classification Product Code
DXY  
Date Received08/26/1983
Decision Date 10/04/1983
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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