Y-TYPE BLOOD ADMINISTRATION SET

Set, Blood Transfusion

PURITAS HEALTH CARE, INC.

The following data is part of a premarket notification filed by Puritas Health Care, Inc. with the FDA for Y-type Blood Administration Set.

Pre-market Notification Details

Device IDK940074
510k NumberK940074
Device Name:Y-TYPE BLOOD ADMINISTRATION SET
ClassificationSet, Blood Transfusion
Applicant PURITAS HEALTH CARE, INC. 219 KENT RD. SUITE 20 New Milford,  CT  06776
ContactThomas P Dimaio
CorrespondentThomas P Dimaio
PURITAS HEALTH CARE, INC. 219 KENT RD. SUITE 20 New Milford,  CT  06776
Product CodeBRZ  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-01-06
Decision Date1994-04-21

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