The following data is part of a premarket notification filed by Nobles-lai Engineering, Inc. with the FDA for Nobles-lai Imaging System.
| Device ID | K920026 |
| 510k Number | K920026 |
| Device Name: | NOBLES-LAI IMAGING SYSTEM |
| Classification | Endoscopic Video Imaging System/component, Gastroenterology-urology |
| Applicant | NOBLES-LAI ENGINEERING, INC. 3178 PULLMAN ST. Costa Mesa, CA 92626 |
| Contact | Karen U Salinas |
| Correspondent | Karen U Salinas NOBLES-LAI ENGINEERING, INC. 3178 PULLMAN ST. Costa Mesa, CA 92626 |
| Product Code | FET |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-01-03 |
| Decision Date | 1992-07-28 |