K833509 is an FDA 510(k) clearance for the CHEMONUCLEOLYSIS TABLE. This device is classified as a Table, Operating-room, Non-electrical (Class I - General Controls, product code FWY).
Submitted by Stryker Corp. (Mchenry, US). The FDA issued a Cleared decision on November 28, 1983, 48 days after receiving the submission on October 11, 1983.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4950.
| 510(k) Number | K833509 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 11, 1983 |
| Decision Date | November 28, 1983 |
| Days to Decision | 48 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | FWY — Table, Operating-room, Non-electrical |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4950 |