SURFLO WINGED INFUSION SET

Set, Administration, Intravascular

TERUMO AMERICA, INC.

The following data is part of a premarket notification filed by Terumo America, Inc. with the FDA for Surflo Winged Infusion Set.

Pre-market Notification Details

Device IDK771204
510k NumberK771204
Device Name:SURFLO WINGED INFUSION SET
ClassificationSet, Administration, Intravascular
Applicant TERUMO AMERICA, 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 Received1977-07-05
Decision Date1977-07-14

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