MICRO VOLUME DOUBLE LINE EXTENSION SET

Set, Administration, Intravascular

TRAVENOL LABORATORIES, S.A.

The following data is part of a premarket notification filed by Travenol Laboratories, S.a. with the FDA for Micro Volume Double Line Extension Set.

Pre-market Notification Details

Device IDK850061
510k NumberK850061
Device Name:MICRO VOLUME DOUBLE LINE EXTENSION SET
ClassificationSet, Administration, Intravascular
Applicant TRAVENOL LABORATORIES, S.A. LONDONDERRY TURNPIKE Hooksett,  NH  03104
ContactRoger A Leroux
CorrespondentRoger A Leroux
TRAVENOL LABORATORIES, S.A. LONDONDERRY TURNPIKE Hooksett,  NH  03104
Product CodeFPA  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-01-08
Decision Date1985-03-27

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