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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name oxygenator, cardiopulmonary bypass
510(k) Number K202510
Device Name AMG PMP Infant
Applicant
Eurosets S.r.l.
Strada Statale 12, n°143
Medolla,  IT I-41036
Applicant Contact Katia Vescovini
Correspondent
Eurosets S.r.l.
Strada Statale 12, n°143
Medolla,  IT I-41036
Correspondent Contact Katia Vescovini
Regulation Number870.4350
Classification Product Code
DTZ  
Date Received08/31/2020
Decision Date 12/10/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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