K834514 is an FDA 510(k) clearance for the FASCIA CUTTER. This device is classified as a Blade, Scalpel (Class I - General Controls, product code GES).
Submitted by Stryker Corp. (Mchenry, US). The FDA issued a Cleared decision on March 12, 1984, 82 days after receiving the submission on December 21, 1983.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K834514 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 21, 1983 |
| Decision Date | March 12, 1984 |
| Days to Decision | 82 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | GES — Blade, Scalpel |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4800 |