The following data is part of a premarket notification filed by Mcconnell Orthopedic with the FDA for Mcconnell Shoulder Brace.
| Device ID | K910974 |
| 510k Number | K910974 |
| Device Name: | MCCONNELL SHOULDER BRACE |
| Classification | Orthosis, Limb Brace |
| Applicant | MCCONNELL ORTHOPEDIC TREEE LINCOLN CENTRE 5430 LBJ FREEWAY SUITE 1540 Dallas, TX 75240 |
| Contact | Dennis T Griggs |
| Correspondent | Dennis T Griggs MCCONNELL ORTHOPEDIC TREEE LINCOLN CENTRE 5430 LBJ FREEWAY SUITE 1540 Dallas, TX 75240 |
| Product Code | IQI |
| CFR Regulation Number | 890.3475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-03-07 |
| Decision Date | 1991-03-21 |