The following data is part of a premarket notification filed by Applied Medical Resources Corp. with the FDA for Applied Ureteral Catheter.
| Device ID | K020577 |
| 510k Number | K020577 |
| Device Name: | APPLIED URETERAL CATHETER |
| Classification | Catheter, Ureteral, Gastro-urology |
| Applicant | APPLIED MEDICAL RESOURCES CORP. 22872 Avenida Empresa Rancho Santa Margarita, CA 92688 |
| Contact | Anil Bhalani |
| Correspondent | Anil Bhalani APPLIED MEDICAL RESOURCES CORP. 22872 Avenida Empresa Rancho Santa Margarita, CA 92688 |
| Product Code | EYB |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-02-21 |
| Decision Date | 2002-05-22 |
| Summary: | summary |