The following data is part of a premarket notification filed by Travenol Laboratories, S.a. with the FDA for Auto Syringe Micro Vol Ext Set W/air Vent Filter.
| Device ID | K860746 |
| 510k Number | K860746 |
| Device Name: | AUTO SYRINGE MICRO VOL EXT SET W/AIR VENT FILTER |
| Classification | Filter, Infusion Line |
| 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 | FPB |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-02-27 |
| Decision Date | 1986-04-07 |