DIDECO D920, LILLIPUT 1 TWIN RESERVOIR

Defoamer, Cardiopulmonary Bypass

DIDECO S.P.A.

The following data is part of a premarket notification filed by Dideco S.p.a. with the FDA for Dideco D920, Lilliput 1 Twin Reservoir.

Pre-market Notification Details

Device IDK984322
510k NumberK984322
Device Name:DIDECO D920, LILLIPUT 1 TWIN RESERVOIR
ClassificationDefoamer, Cardiopulmonary Bypass
Applicant DIDECO S.P.A. 1601 TRAPELO RD. Waltham,  MA  02154
ContactBarry Sall
CorrespondentBarry Sall
DIDECO S.P.A. 1601 TRAPELO RD. Waltham,  MA  02154
Product CodeDTP  
CFR Regulation Number870.4230 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-12-03
Decision Date1999-03-02
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
38033178250222 K984322 000

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