The following data is part of a premarket notification filed by Travenol Laboratories, S.a. with the FDA for Travenol Multiday Infusor 2c1080.
Device ID | K842905 |
510k Number | K842905 |
Device Name: | TRAVENOL MULTIDAY INFUSOR 2C1080 |
Classification | Pump, Infusion |
Applicant | TRAVENOL LABORATORIES, S.A. Deerfield , IL 60015 - |
Product Code | FRN |
CFR Regulation Number | 880.5725 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-07-24 |
Decision Date | 1985-11-01 |