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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 K121536
Device Name INSPIRE 8F OXYGENATOR WITH INTEGRATED ARTERIAL FILTER & HARDSHELL RESERVOIR
Applicant
SORIN GROUP ITALIA S.R.L.
14401 W. 65TH WAY
ARVADA,  CO  80004
Applicant Contact SCOTT LIGHT
Correspondent
SORIN GROUP ITALIA S.R.L.
14401 W. 65TH WAY
ARVADA,  CO  80004
Correspondent Contact SCOTT LIGHT
Regulation Number870.4350
Classification Product Code
DTZ  
Date Received05/24/2012
Decision Date 08/22/2012
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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