The following data is part of a premarket notification filed by Medical Laser, Inc. with the FDA for Medilase 5010 Endoscope Console.
| Device ID | K900380 |
| 510k Number | K900380 |
| Device Name: | MEDILASE 5010 ENDOSCOPE CONSOLE |
| Classification | Endoscopic Video Imaging System/component, Gastroenterology-urology |
| Applicant | MEDICAL LASER, INC. 2605 FERNBROOK LN. Minneapolis, MN 55447 |
| Contact | Sharon Karr |
| Correspondent | Sharon Karr MEDICAL LASER, INC. 2605 FERNBROOK LN. Minneapolis, MN 55447 |
| Product Code | FET |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-01-26 |
| Decision Date | 1990-05-15 |