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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 K923868
Device Name CCS MAESTRO II SERIES 200 CARDIAC PACEMAKER
Applicant
CARDIAC CONTROL SYSTEMS, INC.
3 COMMERCE BLVD.
PALM COAST,  FL  32164
Applicant Contact GREEN
Correspondent
CARDIAC CONTROL SYSTEMS, INC.
3 COMMERCE BLVD.
PALM COAST,  FL  32164
Correspondent Contact GREEN
Regulation Number870.3610
Classification Product Code
DXY  
Date Received08/03/1992
Decision Date 05/14/1993
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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