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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 K854790
Device Name CERYX PACEMAKER MODELS 114, 314 & 614
Applicant
Vitatron Medical BV
6470 Riverview Terrace NE
Minneapolis,  MN  55432
Applicant Contact CONSTANCE G BUNDY
Correspondent
Vitatron Medical BV
6470 Riverview Terrace NE
Minneapolis,  MN  55432
Correspondent Contact CONSTANCE G BUNDY
Regulation Number870.3610
Classification Product Code
DXY  
Date Received11/29/1985
Decision Date 08/28/1986
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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