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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Implantable Pacemaker Pulse-Generator
510(k) Number K831860
Device Name GENERATOR, PULSE, PACEMAKER #532
Applicant
VITATRON MEDICAL BV
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
VITATRON MEDICAL BV
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number870.3610
Classification Product Code
DXY  
Date Received06/10/1983
Decision Date 10/27/1983
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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