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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 K864601
Device Name CCS POLYSAFE(TM) ENDOCARDIAL PACING LEAD
Applicant
Cardiac Control Systems, Inc.
3 Commerce Blvd.
Palm Coast,  FL  32164
Applicant Contact KENNETH J DURBIN
Correspondent
Cardiac Control Systems, Inc.
3 Commerce Blvd.
Palm Coast,  FL  32164
Correspondent Contact KENNETH J DURBIN
Regulation Number870.3680
Classification Product Code
DTB  
Date Received11/24/1986
Decision Date 01/06/1987
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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