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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Permanent Pacemaker Electrode
510(k) Number K832245
Device Name UNIPOLAR-E ENDOCARDIAL TINED LEAD
Applicant
Cook Pacemaker Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Cook Pacemaker Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number870.3680
Classification Product Code
DTB  
Date Received07/11/1983
Decision Date 08/12/1983
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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