IV ADD-ON FILTER ADMINISTRATION SET WITH AND WITHOUT Y CONNECT OR NEEDLELESS ACCESS CONNECTOR

Set, Administration, Intravascular

KAWASUMI LABORATORIES AMERICA, INC.

The following data is part of a premarket notification filed by Kawasumi Laboratories America, Inc. with the FDA for Iv Add-on Filter Administration Set With And Without Y Connect Or Needleless Access Connector.

Pre-market Notification Details

Device IDK030385
510k NumberK030385
Device Name:IV ADD-ON FILTER ADMINISTRATION SET WITH AND WITHOUT Y CONNECT OR NEEDLELESS ACCESS CONNECTOR
ClassificationSet, Administration, Intravascular
Applicant KAWASUMI LABORATORIES AMERICA, INC. 5905 C HAMPTON OAKS PKWY. Tampa,  FL  33610
ContactJack Pavlo
CorrespondentJack Pavlo
KAWASUMI LABORATORIES AMERICA, INC. 5905 C HAMPTON OAKS PKWY. Tampa,  FL  33610
Product CodeFPA  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-02-05
Decision Date2003-04-15
Summary:summary

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