K834513 is an FDA 510(k) clearance for the FIXATION STAPLES..
Submitted by Stryker Corp. (Mchenry, US). The FDA issued a Cleared decision on April 23, 1984, 124 days after receiving the submission on December 21, 1983.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K834513 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 21, 1983 |
| Decision Date | April 23, 1984 |
| Days to Decision | 124 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | — |
| Device Class | — |