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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transmitters And Receivers, Physiological Signal, Radiofrequency
510(k) Number K802357
Device Name TELEMETRY PACEMAKER MONITOR
Applicant
Intermedics, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Intermedics, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number870.2910
Classification Product Code
DRG  
Date Received09/26/1980
Decision Date 02/12/1981
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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