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 |