The following data is part of a premarket notification filed by Applied Medical Resources with the FDA for Flexible Ureteronephrosocope.
| Device ID | K924135 |
| 510k Number | K924135 |
| Device Name: | FLEXIBLE URETERONEPHROSOCOPE |
| Classification | Accessories, Cleaning, For Endoscope |
| Applicant | APPLIED MEDICAL RESOURCES 26051 MERIT CIRCLE BUILDING 104 Laguna Hills, CA 92653 |
| Contact | Jo Stegwell |
| Correspondent | Jo Stegwell APPLIED MEDICAL RESOURCES 26051 MERIT CIRCLE BUILDING 104 Laguna Hills, CA 92653 |
| Product Code | FEB |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-08-18 |
| Decision Date | 1993-04-14 |