The following data is part of a premarket notification filed by Travenol Laboratories, S.a. with the FDA for Miniset Vein Infusion Sets.
Device ID | K843631 |
510k Number | K843631 |
Device Name: | MINISET VEIN INFUSION SETS |
Classification | Set, Administration, Intravascular |
Applicant | TRAVENOL LABORATORIES, S.A. Deerfield , IL 60015 - |
Contact | Patricia S Barsanti |
Correspondent | Patricia S Barsanti TRAVENOL LABORATORIES, S.A. Deerfield , IL 60015 - |
Product Code | FPA |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-09-17 |
Decision Date | 1984-10-19 |