The following data is part of a premarket notification filed by Med Surg Designs, Inc. with the FDA for Soni-lok Scope Stabilizer.
| Device ID | K850122 |
| 510k Number | K850122 |
| Device Name: | SONI-LOK SCOPE STABILIZER |
| Classification | Holder, Camera, Surgical |
| Applicant | MED SURG DESIGNS, INC. 124 PARKER COURT Chardon, OH 44024 |
| Product Code | FXR |
| CFR Regulation Number | 878.4160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-01-14 |
| Decision Date | 1985-02-21 |