The following data is part of a premarket notification filed by Fred Sammons, Inc. with the FDA for Adjustable Polycentric Elbow Hinge.
| Device ID | K831542 |
| 510k Number | K831542 |
| Device Name: | ADJUSTABLE POLYCENTRIC ELBOW HINGE |
| Classification | Orthosis, Limb Brace |
| Applicant | FRED SAMMONS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | IQI |
| CFR Regulation Number | 890.3475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-05-12 |
| Decision Date | 1983-06-24 |