The following data is part of a premarket notification filed by Hosmer Dorrance Corp. with the FDA for Elbow Prosthesis.
| Device ID | K822632 |
| 510k Number | K822632 |
| Device Name: | ELBOW PROSTHESIS |
| Classification | Joint, Elbow, External Limb Component, Powered |
| Applicant | HOSMER DORRANCE CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | IRE |
| CFR Regulation Number | 890.3420 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-08-31 |
| Decision Date | 1982-09-14 |