K-SHIELD PORT ACCESS INFUSION SET

Set, Administration, Intravascular

KAWASUMI LABORATORIES, INC.

The following data is part of a premarket notification filed by Kawasumi Laboratories, Inc. with the FDA for K-shield Port Access Infusion Set.

Pre-market Notification Details

Device IDK060580
510k NumberK060580
Device Name:K-SHIELD PORT ACCESS INFUSION SET
ClassificationSet, Administration, Intravascular
Applicant KAWASUMI LABORATORIES, INC. 4723 OAK FAIR BLVD Tampa,  FL  33610
ContactJack Pavlo
CorrespondentJack Pavlo
KAWASUMI LABORATORIES, INC. 4723 OAK FAIR BLVD Tampa,  FL  33610
Product CodeFPA  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-03-06
Decision Date2006-06-06
Summary:summary

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