The following data is part of a premarket notification filed by Medical Laser, Inc. with the FDA for Medilase Series 2200 Endoscope.
| Device ID | K901464 |
| 510k Number | K901464 |
| Device Name: | MEDILASE SERIES 2200 ENDOSCOPE |
| Classification | Endoscope, Rigid |
| 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 | GCM |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-03-28 |
| Decision Date | 1990-08-07 |