The following data is part of a premarket notification filed by Venusa Ltd. with the FDA for Huber Needle Infusion Set Model #20g01 & Y-site Model #20g01y.
| Device ID | K981683 |
| 510k Number | K981683 |
| Device Name: | HUBER NEEDLE INFUSION SET MODEL #20G01 & Y-SITE MODEL #20G01Y |
| Classification | Set, Administration, Intravascular |
| Applicant | VENUSA LTD. 31C BUTTERFIELD TRAIL El Paso, TX 79906 |
| Contact | Neil Kulkarni |
| Correspondent | Neil Kulkarni VENUSA LTD. 31C BUTTERFIELD TRAIL El Paso, TX 79906 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-05-13 |
| Decision Date | 1998-07-28 |
| Summary: | summary |