SOLUTION ADMIN. SETS W/FLASHBALL

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 Solution Admin. Sets W/flashball.

Pre-market Notification Details

Device IDK831311
510k NumberK831311
Device Name:SOLUTION ADMIN. SETS W/FLASHBALL
ClassificationSet, Administration, Intravascular
Applicant TRAVENOL LABORATORIES, S.A. 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 Received1983-04-22
Decision Date1983-06-08

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