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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 K960849
Device Name MAGNO ALARM
Applicant
Cardiac Assist Devices, Inc.
11000 Cedar Ave., Suite 451
Cleveland,  OH  44106 -3052
Applicant Contact RASSOLL RASHIDI
Correspondent
Cardiac Assist Devices, Inc.
11000 Cedar Ave., Suite 451
Cleveland,  OH  44106 -3052
Correspondent Contact RASSOLL RASHIDI
Regulation Number870.3690
Classification Product Code
DTG  
Date Received02/20/1996
Decision Date 03/26/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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