The following data is part of a premarket notification filed by Travenol Laboratories, S.a. with the FDA for Solution Admin. Sets W/flashball.
Device ID | K831311 |
510k Number | K831311 |
Device Name: | SOLUTION ADMIN. SETS W/FLASHBALL |
Classification | Set, Administration, Intravascular |
Applicant | TRAVENOL LABORATORIES, S.A. 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 | 1983-04-22 |
Decision Date | 1983-06-08 |