KAWASUMI LABORATORIES EMPTY SOLUTION CONTAINER

Container, I.v.

KAWASUMI LABORATORIES, INC.

The following data is part of a premarket notification filed by Kawasumi Laboratories, Inc. with the FDA for Kawasumi Laboratories Empty Solution Container.

Pre-market Notification Details

Device IDK061197
510k NumberK061197
Device Name:KAWASUMI LABORATORIES EMPTY SOLUTION CONTAINER
ClassificationContainer, I.v.
Applicant KAWASUMI LABORATORIES, INC. 1601 K STREET, N.W. Washington,  DC  20006
ContactSuzan Onel
CorrespondentSuzan Onel
KAWASUMI LABORATORIES, INC. 1601 K STREET, N.W. Washington,  DC  20006
Product CodeKPE  
CFR Regulation Number880.5025 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-04-28
Decision Date2006-06-30
Summary:summary

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