Y-TYPE BLOOD ADMINISTRATION SET MODEL #HT-TR2

Set, Blood Transfusion

HAEMOTRONIC, INC.

The following data is part of a premarket notification filed by Haemotronic, Inc. with the FDA for Y-type Blood Administration Set Model #ht-tr2.

Pre-market Notification Details

Device IDK921595
510k NumberK921595
Device Name:Y-TYPE BLOOD ADMINISTRATION SET MODEL #HT-TR2
ClassificationSet, Blood Transfusion
Applicant HAEMOTRONIC, INC. 45 KULICK RD. Fairfield,  NJ  07004
ContactWiller Ghelfi
CorrespondentWiller Ghelfi
HAEMOTRONIC, INC. 45 KULICK RD. Fairfield,  NJ  07004
Product CodeBRZ  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-04-03
Decision Date1992-12-24

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.