K823059 is an FDA 510(k) clearance for the DOSIMETRY RELEASE OF RADIATION STERIL...
Submitted by Biomet, Inc. (Walker, US). The FDA issued a Cleared decision on March 17, 1983, 150 days after receiving the submission on October 18, 1982.
This device falls under the Orthopedic FDA review panel.
| 510(k) Number | K823059 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 18, 1982 |
| Decision Date | March 17, 1983 |
| Days to Decision | 150 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | — |
| Product Code | — |
| Device Class | — |