KAWASUMI LABORATORIES PHILEBOTOMY SET

Set, I.v. Fluid Transfer

KAWASUMI LABORATORIES CO., LTD.

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

Pre-market Notification Details

Device IDK994323
510k NumberK994323
Device Name:KAWASUMI LABORATORIES PHILEBOTOMY SET
ClassificationSet, I.v. Fluid Transfer
Applicant KAWASUMI LABORATORIES CO., LTD. 1900 K ST. N.W. Washington,  DC  20006
ContactDonald R Stone
CorrespondentDonald R Stone
KAWASUMI LABORATORIES CO., LTD. 1900 K ST. N.W. Washington,  DC  20006
Product CodeLHI  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-12-22
Decision Date2000-03-08
Summary:summary

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