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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 K852435
Device Name CCS IMPLANTABLE MAESTRO SERIES 100 CARDIAC PACEMA
Applicant
Cardiac Control Systems, Inc.
3 Commerce Blvd.
Palm Coast,  FL  32164
Applicant Contact KENNETH J DURDIN
Correspondent
Cardiac Control Systems, Inc.
3 Commerce Blvd.
Palm Coast,  FL  32164
Correspondent Contact KENNETH J DURDIN
Regulation Number870.3610
Classification Product Code
DXY  
Date Received06/10/1985
Decision Date 08/06/1985
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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