The following data is part of a premarket notification filed by Applied Medical Resources Corp. with the FDA for Modification To Ureteral Stent.
| Device ID | K040760 |
| 510k Number | K040760 |
| Device Name: | MODIFICATION TO URETERAL STENT |
| Classification | Stent, Ureteral |
| Applicant | APPLIED MEDICAL RESOURCES CORP. 22872 Avenida Empresa Rancho Santa Margarita, CA 92688 |
| Contact | Cheryl Blake |
| Correspondent | Andrew Nguyen APPLIED MEDICAL RESOURCES CORP. 22872 Avenida Empresa Rancho Santa Margarita, CA 92688 |
| Product Code | FAD |
| CFR Regulation Number | 876.4620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-03-25 |
| Decision Date | 2004-10-15 |
| Summary: | summary |