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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 K823033
Device Name ELECTRODE, PACEMAKER, PERMANENT
Applicant
Pacesetter Systems
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Pacesetter Systems
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number870.3680
Classification Product Code
DTB  
Date Received10/14/1982
Decision Date 12/30/1982
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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