TRAVENOL RECONSTITUTION DEVICE W/ADMIX CAP

Set, I.v. Fluid Transfer

TRAVENOL LABORATORIES, S.A.

The following data is part of a premarket notification filed by Travenol Laboratories, S.a. with the FDA for Travenol Reconstitution Device W/admix Cap.

Pre-market Notification Details

Device IDK844340
510k NumberK844340
Device Name:TRAVENOL RECONSTITUTION DEVICE W/ADMIX CAP
ClassificationSet, I.v. Fluid Transfer
Applicant TRAVENOL LABORATORIES, S.A. Deerfield,  IL  60015
ContactDennis A Ocwieja
CorrespondentDennis A Ocwieja
TRAVENOL LABORATORIES, S.A. Deerfield,  IL  60015
Product CodeLHI  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-11-08
Decision Date1985-01-09

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