The following data is part of a premarket notification filed by Travenol Laboratories, S.a. with the FDA for Micro Volume Double Line Extension Set.
| Device ID | K850061 |
| 510k Number | K850061 |
| Device Name: | MICRO VOLUME DOUBLE LINE EXTENSION SET |
| Classification | Set, Administration, Intravascular |
| Applicant | TRAVENOL LABORATORIES, S.A. LONDONDERRY TURNPIKE Hooksett, NH 03104 |
| Contact | Roger A Leroux |
| Correspondent | Roger A Leroux TRAVENOL LABORATORIES, S.A. LONDONDERRY TURNPIKE Hooksett, NH 03104 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-01-08 |
| Decision Date | 1985-03-27 |