D732 MICRO 27 PH.I.S.I.O. ADULT ARTERIAL FILTER

Filter, Blood, Cardiopulmonary Bypass, Arterial Line

DIDECO S.R.L.

The following data is part of a premarket notification filed by Dideco S.r.l. with the FDA for D732 Micro 27 Ph.i.s.i.o. Adult Arterial Filter.

Pre-market Notification Details

Device IDK052717
510k NumberK052717
Device Name:D732 MICRO 27 PH.I.S.I.O. ADULT ARTERIAL FILTER
ClassificationFilter, Blood, Cardiopulmonary Bypass, Arterial Line
Applicant DIDECO S.R.L. 200 WEST STREET Waltham,  MA  02451
ContactBarry Sall
CorrespondentBarry Sall
DIDECO S.R.L. 200 WEST STREET Waltham,  MA  02451
Product CodeDTM  
CFR Regulation Number870.4260 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-09-29
Decision Date2005-10-20
Summary:summary

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