AIR PURGE CONTROL SYSTEM FOR S5 SYSTEM MODEL 23-45-05

Console, Heart-lung Machine, Cardiopulmonary Bypass

SORIN GROUP DEUTSCHLAND GMBH

The following data is part of a premarket notification filed by Sorin Group Deutschland Gmbh with the FDA for Air Purge Control System For S5 System Model 23-45-05.

Pre-market Notification Details

Device IDK091007
510k NumberK091007
Device Name:AIR PURGE CONTROL SYSTEM FOR S5 SYSTEM MODEL 23-45-05
ClassificationConsole, Heart-lung Machine, Cardiopulmonary Bypass
Applicant SORIN GROUP DEUTSCHLAND GMBH 49 PLAIN STREET North Attleboro,  MA  02760
ContactRosina Robinson
CorrespondentRosina Robinson
SORIN GROUP DEUTSCHLAND GMBH 49 PLAIN STREET North Attleboro,  MA  02760
Product CodeDTQ  
CFR Regulation Number870.4220 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-04-09
Decision Date2009-07-02
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04033817902638 K091007 000

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