The following data is part of a premarket notification filed by Circon Video with the FDA for Flexible Pediatric Cystoureteroscope, Model Aur- 735.
| Device ID | K012929 |
| 510k Number | K012929 |
| Device Name: | FLEXIBLE PEDIATRIC CYSTOURETEROSCOPE, MODEL AUR- 735 |
| Classification | Cystoscope And Accessories, Flexible/rigid |
| Applicant | CIRCON VIDEO 6500 HOLLISTER AVE. Santa Barbara, CA 93117 -3019 |
| Contact | Wayne Sterner |
| Correspondent | Wayne Sterner CIRCON VIDEO 6500 HOLLISTER AVE. Santa Barbara, CA 93117 -3019 |
| Product Code | FAJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-08-31 |
| Decision Date | 2001-11-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00821925008816 | K012929 | 000 |
| 00821925027312 | K012929 | 000 |