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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Programmer, Pacemaker
510(k) Number K860546
Device Name DIALOG PROGRAMMER 700 - PROGRAM VERSION 6.37
Applicant
Pacesetter Systems
12884 Bradley Ave.
Sylmar,  CA  91342
Applicant Contact ANITA POWE
Correspondent
Pacesetter Systems
12884 Bradley Ave.
Sylmar,  CA  91342
Correspondent Contact ANITA POWE
Regulation Number870.3700
Classification Product Code
KRG  
Date Received02/13/1986
Decision Date 04/23/1986
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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