XRES BLOOD COLLECTION RESERVOIR

Reservoir, Blood, Cardiopulmonary Bypass

SORIN GROUP ITALIA S.R.L

The following data is part of a premarket notification filed by Sorin Group Italia S.r.l with the FDA for Xres Blood Collection Reservoir.

Pre-market Notification Details

Device IDK100507
510k NumberK100507
Device Name:XRES BLOOD COLLECTION RESERVOIR
ClassificationReservoir, Blood, Cardiopulmonary Bypass
Applicant SORIN GROUP ITALIA S.R.L PAREXEL CONSULTING 195 WEST STREET Waltham,  MA  02451
ContactBarry Sall
CorrespondentBarry Sall
SORIN GROUP ITALIA S.R.L PAREXEL CONSULTING 195 WEST STREET Waltham,  MA  02451
Product CodeDTN  
CFR Regulation Number870.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-02-22
Decision Date2010-03-24

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08033178110846 K100507 000

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