K811205 is an FDA 510(k) clearance for the MOLDED POLYSULFONE TRIAL PROSTHESIS. This device is classified as a Template (Class I - General Controls, product code HWT).
Submitted by Shannon Group (Mchenry, US). The FDA issued a Cleared decision on May 21, 1981, 20 days after receiving the submission on May 1, 1981.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.4800.
| 510(k) Number | K811205 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 01, 1981 |
| Decision Date | May 21, 1981 |
| Days to Decision | 20 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | — |
| Product Code | HWT — Template |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 888.4800 |