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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 K880326
Device Name MAESTRO(R) MODELS 115, 118, 215 AND 218 PACEMAKERS
Applicant
Cardiac Control Systems, Inc.
3 Commerce Blvd.
Palm Coast,  FL  32164
Applicant Contact Scott J Mindrebo
Correspondent
Cardiac Control Systems, Inc.
3 Commerce Blvd.
Palm Coast,  FL  32164
Correspondent Contact Scott J Mindrebo
Regulation Number870.3610
Classification Product Code
DXY  
Date Received01/26/1988
Decision Date 04/11/1988
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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