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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 K861009
Device Name BIPOLAR CARDIAC PACEMAKER, MODEL 110
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 Number870.3610
Classification Product Code
DXY  
Date Received03/18/1986
Decision Date 04/23/1986
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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