STERILE DISP. BUTTERFLY INFUSION SET

Set, Administration, Intravascular

LEE MEDICAL INTL., INC.

The following data is part of a premarket notification filed by Lee Medical Intl., Inc. with the FDA for Sterile Disp. Butterfly Infusion Set.

Pre-market Notification Details

Device IDK832104
510k NumberK832104
Device Name:STERILE DISP. BUTTERFLY INFUSION SET
ClassificationSet, Administration, Intravascular
Applicant LEE MEDICAL INTL., INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeFPA  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-06-23
Decision Date1983-09-12

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.