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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Reservoir, Blood, Cardiopulmonary Bypass
510(k) Number K223361
Device Name BMR 1900 PHISIO
Applicant
Sorin Group Italia S.R.L.
Via Statale 12 Nord. 86
Mirandola,  IT 41037
Applicant Contact Luigi Vecchi
Correspondent
Sorin Group Italia S.R.L.
Via Statale 12 Nord. 86
Mirandola,  IT 41037
Correspondent Contact Luigi Vecchi
Regulation Number870.4400
Classification Product Code
DTN  
Date Received11/03/2022
Decision Date 06/10/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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