BLOOD/SOLUTION ADMINISTRATION SET, MODEL 33.015

Set, Blood Transfusion

TUTA HEALTHCARE PTY LIMITED

The following data is part of a premarket notification filed by Tuta Healthcare Pty Limited with the FDA for Blood/solution Administration Set, Model 33.015.

Pre-market Notification Details

Device IDK023039
510k NumberK023039
Device Name:BLOOD/SOLUTION ADMINISTRATION SET, MODEL 33.015
ClassificationSet, Blood Transfusion
Applicant TUTA HEALTHCARE PTY LIMITED 318-332 BURNS BAY ROAD LANE COVE Sydney Nsw,  AU 2066
ContactOmid Souresrafil
CorrespondentOmid Souresrafil
TUTA HEALTHCARE PTY LIMITED 318-332 BURNS BAY ROAD LANE COVE Sydney Nsw,  AU 2066
Product CodeBRZ  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-09-12
Decision Date2002-11-07
Summary:summary

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