The following data is part of a premarket notification filed by Terumo America, Inc. with the FDA for Surflo Winged Infusion Set.
Device ID | K771204 |
510k Number | K771204 |
Device Name: | SURFLO WINGED INFUSION SET |
Classification | Set, Administration, Intravascular |
Applicant | TERUMO AMERICA, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FPA |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1977-07-05 |
Decision Date | 1977-07-14 |