K843348 is an FDA 510(k) clearance for the NISONSON WIRE & DRILL GUIDE SYS..
Submitted by Stryker Corp. (Kalamazoo, US). The FDA issued a Cleared decision on October 31, 1984, 65 days after receiving the submission on August 27, 1984.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K843348 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 27, 1984 |
| Decision Date | October 31, 1984 |
| Days to Decision | 65 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | — |
| Device Class | — |