The following data is part of a premarket notification filed by Travenol Laboratories, S.a. with the FDA for Flo-gard 2000 Enternal Pump & Travasorb.
Device ID | K823063 |
510k Number | K823063 |
Device Name: | FLO-GARD 2000 ENTERNAL PUMP & TRAVASORB |
Classification | Pump, Infusion |
Applicant | TRAVENOL LABORATORIES, S.A. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FRN |
CFR Regulation Number | 880.5725 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-10-18 |
Decision Date | 1982-11-30 |