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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Magnet, Test, Pacemaker
510(k) Number K895110
Device Name MAESTRO PACEMAKER TEST MAGNET
Applicant
Cardiac Control Systems, Inc.
3 Commerce Blvd.
Palm Coast,  FL  32164
Applicant Contact SCOTT MINDREBO
Correspondent
Cardiac Control Systems, Inc.
3 Commerce Blvd.
Palm Coast,  FL  32164
Correspondent Contact SCOTT MINDREBO
Regulation Number870.3690
Classification Product Code
DTG  
Date Received08/15/1989
Decision Date 09/26/1989
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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