The following data is part of a premarket notification filed by Sandhill Scientific, Inc. with the FDA for Model Osp, Sandhill Ams.
| Device ID | K904231 |
| 510k Number | K904231 |
| Device Name: | MODEL OSP, SANDHILL AMS |
| Classification | Stent, Ureteral |
| Applicant | SANDHILL SCIENTIFIC, INC. 1501-N WEST CAMPUS DR. Littleton, CO 80120 -4535 |
| Contact | Judy Griffith |
| Correspondent | Judy Griffith SANDHILL SCIENTIFIC, INC. 1501-N WEST CAMPUS DR. Littleton, CO 80120 -4535 |
| Product Code | FAD |
| CFR Regulation Number | 876.4620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-08-28 |
| Decision Date | 1991-01-02 |