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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name filter, blood, cardiopulmonary bypass, arterial line
510(k) Number K063255
Device Name D130 PH.I.S.I.O DIDECO KIDS NEONATAL ARTERIAL FILTER WITH 40 MICRON SCREEN PHOSPHORYLCHOLINE COATED
Applicant
SORIN GROUP ITALIA S.R.L
200 WEST STREET
WALTHAM,  MA  02451
Applicant Contact BARRY SALL
Correspondent
SORIN GROUP ITALIA S.R.L
200 WEST STREET
WALTHAM,  MA  02451
Correspondent Contact BARRY SALL
Regulation Number870.4260
Classification Product Code
DTM  
Date Received10/27/2006
Decision Date 01/11/2007
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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