INTERMITTENT INJECTION SITE

Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days

KAWASUMI LABORATORIES CO., LTD.

The following data is part of a premarket notification filed by Kawasumi Laboratories Co., Ltd. with the FDA for Intermittent Injection Site.

Pre-market Notification Details

Device IDK923323
510k NumberK923323
Device Name:INTERMITTENT INJECTION SITE
ClassificationCatheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Applicant KAWASUMI LABORATORIES CO., LTD. KAWASUMI BLDG. 3-28-15 MINAMI-OHI, SHINAGAWA-KU Tokyo,  JP 140
ContactShozo Moriyama
CorrespondentShozo Moriyama
KAWASUMI LABORATORIES CO., LTD. KAWASUMI BLDG. 3-28-15 MINAMI-OHI, SHINAGAWA-KU Tokyo,  JP 140
Product CodeFOZ  
CFR Regulation Number880.5200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-07-07
Decision Date1993-07-13

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