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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection)
510(k) Number K202876
Device Name Confirm Rx Insertable Cardiac Monitor
Applicant
Abbott (St. Jude Medical)
15900 Valley View Ct.
Sylmar,  CA  91342
Applicant Contact Juni Sarkar
Correspondent
Abbott (St. Jude Medical)
15900 Valley View Ct.
Sylmar,  CA  91342
Correspondent Contact Juni Sarkar
Regulation Number870.2800
Classification Product Code
MXC  
Subsequent Product Code
DSI  
Date Received09/28/2020
Decision Date 12/01/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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