K831512 is an FDA 510(k) clearance for the DOSIMETRY RELEASE OF RADIATION STERILIZ. This device is classified as a Prosthesis, Hip, Cement Restrictor (Class II - Special Controls, product code JDK).
Submitted by Biomet, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 29, 1983, 140 days after receiving the submission on May 12, 1983.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 878.3300.
| 510(k) Number | K831512 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 12, 1983 |
| Decision Date | September 29, 1983 |
| Days to Decision | 140 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | — |
| Product Code | JDK — Prosthesis, Hip, Cement Restrictor |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.3300 |