The following data is part of a premarket notification filed by Medical Concepts, Inc. with the FDA for Karl Storz Endovision Urocam/hysterocam.
| Device ID | K940283 |
| 510k Number | K940283 |
| Device Name: | KARL STORZ ENDOVISION UROCAM/HYSTEROCAM |
| Classification | Endoscopic Video Imaging System/component, Gastroenterology-urology |
| Applicant | MEDICAL CONCEPTS, INC. 175 B CREMONA DR. Goleta, CA 93117 |
| Contact | John B Tedeschi |
| Correspondent | John B Tedeschi MEDICAL CONCEPTS, INC. 175 B CREMONA DR. Goleta, CA 93117 |
| Product Code | FET |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-01-19 |
| Decision Date | 1994-09-28 |