The following data is part of a premarket notification filed by Medical Laser, Inc. with the FDA for Medilase Semi-rigid Instrod Sheath Series Ae1000.
| Device ID | K912265 |
| 510k Number | K912265 |
| Device Name: | MEDILASE SEMI-RIGID INSTROD SHEATH SERIES AE1000 |
| Classification | Endoscopic Access Overtube, Gastroenterology-urology |
| Applicant | MEDICAL LASER, INC. 2605 FERNBROOK LN. Minneapolis, MN 55447 |
| Contact | Gregory J Mathison |
| Correspondent | Gregory J Mathison MEDICAL LASER, INC. 2605 FERNBROOK LN. Minneapolis, MN 55447 |
| Product Code | FED |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-05-22 |
| Decision Date | 1991-10-10 |