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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name cable, transducer and electrode, patient, (including connector)
510(k) Number K200674
Device Name AtriAmp, AtriAmp - Pacing Cable Medtronic Connector, AtriAmp - Pacing Cable Oscor Connector
Applicant
Atrility Medical, LLC
313 Price Place, Suite 13
madison,  WI  53705
Applicant Contact matthew knoespel
Correspondent
Quality & Regulatory Associates, LLC
800 Levanger Lane
stoughton,  WI  53589
Correspondent Contact gary syring
Regulation Number870.2900
Classification Product Code
DSA  
Subsequent Product Code
IKD  
Date Received03/16/2020
Decision Date 07/02/2020
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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