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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Detector And Alarm, Arrhythmia
510(k) Number K852654
Device Name CARDIAC COMMUNICATOR 2000
Applicant
Creative Medical, Inc.
725 N. Black Horse Pike
Runnemede,  NJ  08078
Applicant Contact ALAN P SCHWARTZ
Correspondent
Creative Medical, Inc.
725 N. Black Horse Pike
Runnemede,  NJ  08078
Correspondent Contact ALAN P SCHWARTZ
Regulation Number870.1025
Classification Product Code
DSI  
Date Received06/24/1985
Decision Date 12/04/1985
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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