KAWASUMI Y-TYPE BLOOD ADMINISTRATION SET

Set, Administration, Intravascular

KAWASUMI LABORATORIES CO., LTD.

The following data is part of a premarket notification filed by Kawasumi Laboratories Co., Ltd. with the FDA for Kawasumi Y-type Blood Administration Set.

Pre-market Notification Details

Device IDK896892
510k NumberK896892
Device Name:KAWASUMI Y-TYPE BLOOD ADMINISTRATION SET
ClassificationSet, Administration, Intravascular
Applicant KAWASUMI LABORATORIES CO., LTD. 15902 S. WESTERN AVE. NO. 200 Gardena,  CA  90247
ContactKenjiro Tani
CorrespondentKenjiro Tani
KAWASUMI LABORATORIES CO., LTD. 15902 S. WESTERN AVE. NO. 200 Gardena,  CA  90247
Product CodeFPA  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-12-08
Decision Date1990-09-12

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