KAWASUMI I.V. ADMINISTRATION SET WITH BURETTE

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 I.v. Administration Set With Burette.

Pre-market Notification Details

Device IDK896893
510k NumberK896893
Device Name:KAWASUMI I.V. ADMINISTRATION SET WITH BURETTE
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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