The following data is part of a premarket notification filed by Travenol Laboratories, S.a. with the FDA for Solution Administration Set.
Device ID | K860541 |
510k Number | K860541 |
Device Name: | SOLUTION ADMINISTRATION SET |
Classification | Set, Administration, Intravascular |
Applicant | TRAVENOL LABORATORIES, S.A. Deerfield, IL 60015 |
Contact | Brian Stembal |
Correspondent | Brian Stembal TRAVENOL LABORATORIES, S.A. Deerfield, IL 60015 |
Product Code | FPA |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-02-12 |
Decision Date | 1986-03-25 |