The following data is part of a premarket notification filed by Venusa Ltd. with the FDA for Fluven Sets (ext-1, Ext-2, Ext-3, Ext-4).
| Device ID | K812981 |
| 510k Number | K812981 |
| Device Name: | FLUVEN SETS (EXT-1, EXT-2, EXT-3, EXT-4) |
| Classification | Tubing, Fluid Delivery |
| Applicant | VENUSA LTD. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FPK |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-10-23 |
| Decision Date | 1981-11-06 |