The following data is part of a premarket notification filed by Shannon Group with the FDA for Molded Polysulfone Trial Prosthesis.
| Device ID | K811205 |
| 510k Number | K811205 |
| Device Name: | MOLDED POLYSULFONE TRIAL PROSTHESIS |
| Classification | Template |
| Applicant | SHANNON GROUP 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HWT |
| CFR Regulation Number | 888.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-05-01 |
| Decision Date | 1981-05-21 |