K802479 is an FDA 510(k) clearance for the SURGICAL KNIVES & PROBES. This device is classified as a Probe (Class I - General Controls, product code HXB).
Submitted by Eder Instrument Co, Inc. (Walker, US). The FDA issued a Cleared decision on October 31, 1980, 24 days after receiving the submission on October 7, 1980.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.4540.
| 510(k) Number | K802479 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 07, 1980 |
| Decision Date | October 31, 1980 |
| Days to Decision | 24 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | — |
| Product Code | HXB — Probe |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 888.4540 |