The following data is part of a premarket notification filed by Travenol Laboratories, S.a. with the FDA for New Travenol Roller Clamp-solution Admin. Set.
| Device ID | K854517 |
| 510k Number | K854517 |
| Device Name: | NEW TRAVENOL ROLLER CLAMP-SOLUTION ADMIN. SET |
| Classification | Clamp, Line |
| Applicant | TRAVENOL LABORATORIES, S.A. Deerfield, IL 60015 |
| Contact | Brian Stembal |
| Correspondent | Brian Stembal TRAVENOL LABORATORIES, S.A. Deerfield, IL 60015 |
| Product Code | FKK |
| CFR Regulation Number | 876.4730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-11-12 |
| Decision Date | 1985-12-02 |