The following data is part of a premarket notification filed by Travenol Laboratories, S.a. with the FDA for The Travenol 5 Ml/hr Infusor.
Device ID | K853881 |
510k Number | K853881 |
Device Name: | THE TRAVENOL 5 ML/HR INFUSOR |
Classification | Pump, Infusion |
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 | FRN |
CFR Regulation Number | 880.5725 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-09-19 |
Decision Date | 1985-12-02 |