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FDA 510(k) Application Details - K202206
Device Classification Name
Oxygenator, Cardiopulmonary Bypass
More FDA Info for this Device
510(K) Number
K202206
Device Name
Oxygenator, Cardiopulmonary Bypass
Applicant
Eurosets S.r.l.
Strada Statale 12, n░143
Medolla i-41036 IT
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Contact
Katia Vescovini
Other 510(k) Applications for this Contact
Regulation Number
870.4350
More FDA Info for this Regulation Number
Classification Product Code
DTZ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/05/2020
Decision Date
04/01/2021
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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