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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 K860846
Device Name CORDIS HI-FLEX PERVENOUS BIPOLAR LEAD
Applicant
Cordis Corp.
P.O. Box 025700
Miami,  FL  33102
Applicant Contact MARK D KRAMER
Correspondent
Cordis Corp.
P.O. Box 025700
Miami,  FL  33102
Correspondent Contact MARK D KRAMER
Regulation Number870.3680
Classification Product Code
DTB  
Date Received03/06/1986
Decision Date 06/26/1986
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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