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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 K863417
Device Name CORDIS MULTICOR II MODEL 402D PACER
Applicant
Cordis Corp.
P.O. Box 025700
Miami,  FL  33102
Applicant Contact CIPORKIN, M.S.
Correspondent
Cordis Corp.
P.O. Box 025700
Miami,  FL  33102
Correspondent Contact CIPORKIN, M.S.
Regulation Number870.3610
Classification Product Code
DXY  
Date Received09/03/1986
Decision Date 10/08/1986
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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