The following data is part of a premarket notification filed by Medical Laser, Inc. with the FDA for Laser Endoscope Disc Decompression Kits.
| Device ID | K913136 |
| 510k Number | K913136 |
| Device Name: | LASER ENDOSCOPE DISC DECOMPRESSION KITS |
| Classification | General Surgery Tray |
| 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 | LRO |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-07-16 |
| Decision Date | 1991-11-01 |