The following data is part of a premarket notification filed by Artes Medical Usa, Inc. with the FDA for Uroscope, Artes Medical, Usa.
| Device ID | K003988 |
| 510k Number | K003988 |
| Device Name: | UROSCOPE, ARTES MEDICAL, USA |
| Classification | Cystoscope And Accessories, Flexible/rigid |
| Applicant | ARTES MEDICAL USA, INC. 4660 LA JOLLA VILLAGE DR. CENTER 1, SUITE 825 San Diego, CA 92122 |
| Contact | William Kirkpatrick |
| Correspondent | William Kirkpatrick ARTES MEDICAL USA, INC. 4660 LA JOLLA VILLAGE DR. CENTER 1, SUITE 825 San Diego, CA 92122 |
| Product Code | FAJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-12-26 |
| Decision Date | 2001-09-06 |