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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 K853914
Device Name PACESETTER SYS FAST PASS ENDOCARDIAL LEAD 856 INLI
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 Received09/23/1985
Decision Date 12/03/1985
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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