The following data is part of a premarket notification filed by Applied Urology, Inc. with the FDA for Ureteral Access Set.
| Device ID | K896385 |
| 510k Number | K896385 |
| Device Name: | URETERAL ACCESS SET |
| Classification | Catheter, Urological |
| Applicant | APPLIED UROLOGY, INC. 26051 MERIT CIRCLE, BLDG. 104 Laguna Hills, CA 92653 |
| Contact | Nabil Hilal |
| Correspondent | Nabil Hilal APPLIED UROLOGY, INC. 26051 MERIT CIRCLE, BLDG. 104 Laguna Hills, CA 92653 |
| Product Code | KOD |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-11-06 |
| Decision Date | 1990-01-22 |