The following data is part of a premarket notification filed by Medical Emergency Support Equipment with the FDA for Schul-tec Immobilizer.
| Device ID | K926291 |
| 510k Number | K926291 |
| Device Name: | SCHUL-TEC IMMOBILIZER |
| Classification | Orthosis, Cervical |
| Applicant | MEDICAL EMERGENCY SUPPORT EQUIPMENT 1642 FOREST HILLS DR. St. Charles, MO 63303 |
| Contact | Gregg R Schulte |
| Correspondent | Gregg R Schulte MEDICAL EMERGENCY SUPPORT EQUIPMENT 1642 FOREST HILLS DR. St. Charles, MO 63303 |
| Product Code | IQK |
| CFR Regulation Number | 890.3490 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-12-14 |
| Decision Date | 1993-03-30 |