The following data is part of a premarket notification filed by Travenol Laboratories, S.a. with the FDA for Travenol Reconstitution Device W/admix Cap.
Device ID | K844340 |
510k Number | K844340 |
Device Name: | TRAVENOL RECONSTITUTION DEVICE W/ADMIX CAP |
Classification | Set, I.v. Fluid Transfer |
Applicant | TRAVENOL LABORATORIES, S.A. Deerfield, IL 60015 |
Contact | Dennis A Ocwieja |
Correspondent | Dennis A Ocwieja TRAVENOL LABORATORIES, S.A. Deerfield, IL 60015 |
Product Code | LHI |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-11-08 |
Decision Date | 1985-01-09 |