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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 K861464
Device Name LEAD BODY CHANGES TO HI PERFORM & FAST-PASS LEADS
Applicant
Pacesetter Systems
12884 Bradley Ave.
Sylmar,  CA  91342
Applicant Contact RITA BROWN
Correspondent
Pacesetter Systems
12884 Bradley Ave.
Sylmar,  CA  91342
Correspondent Contact RITA BROWN
Regulation Number870.3680
Classification Product Code
DTB  
Date Received04/21/1986
Decision Date 05/19/1986
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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