The following data is part of a premarket notification filed by Travenol Laboratories, S.a. with the FDA for Continu-flo Solution Administration.
Device ID | K831668 |
510k Number | K831668 |
Device Name: | CONTINU-FLO SOLUTION ADMINISTRATION |
Classification | Filter, Infusion Line |
Applicant | TRAVENOL LABORATORIES, S.A. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | FPB |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-05-23 |
Decision Date | 1983-08-16 |