The following data is part of a premarket notification filed by Gambro, Inc. with the FDA for Gambro A-v Fistula Needle Set.
| Device ID | K802956 |
| 510k Number | K802956 |
| Device Name: | GAMBRO A-V FISTULA NEEDLE SET |
| Classification | Needle, Fistula |
| Applicant | GAMBRO, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FIE |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-11-20 |
| Decision Date | 1980-12-22 |