The following data is part of a premarket notification filed by Travenol Laboratories, S.a. with the FDA for Sliding Reconstitution Device W/admix Vialex Plast.
| Device ID | K853830 |
| 510k Number | K853830 |
| Device Name: | SLIDING RECONSTITUTION DEVICE W/ADMIX VIALEX PLAST |
| Classification | Set, I.v. Fluid Transfer |
| Applicant | TRAVENOL LABORATORIES, S.A. Deerfield, IL 60015 |
| Contact | Patricia Barsanti |
| Correspondent | Patricia Barsanti 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 | 1985-09-13 |
| Decision Date | 1985-11-06 |