The following data is part of a premarket notification filed by Applied Urology, Inc. with the FDA for Ureteropyelogram Cath For Retrograde Dye Injection.
| Device ID | K903994 |
| 510k Number | K903994 |
| Device Name: | URETEROPYELOGRAM CATH FOR RETROGRADE DYE INJECTION |
| Classification | Catheter, Ureteral Disposable (x-ray) |
| Applicant | APPLIED UROLOGY, INC. 26051 MERIT CIRCLE, BLDG. 104 Laguna Hills, CA 92653 |
| Contact | Jo Stegwell |
| Correspondent | Jo Stegwell APPLIED UROLOGY, INC. 26051 MERIT CIRCLE, BLDG. 104 Laguna Hills, CA 92653 |
| Product Code | FGF |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-08-29 |
| Decision Date | 1990-10-19 |