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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 K161733
Device Name INSPIRE SVR 1200, INSPIRE 6F C, INSPIRE 8F C
Applicant
Sorin Group Italia S.R.L.
86, Via Statale 12 Nord
Mirandola,  IT 41037
Applicant Contact Luigi Vecchi
Correspondent
Sorin Group USA, Inc.
14401 W. 65th Way
Arvada,  CO  80004
Correspondent Contact Scott Light
Regulation Number870.4400
Classification Product Code
DTN  
Date Received06/23/2016
Decision Date 03/08/2017
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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