K942603 is an FDA 510(k) clearance for the ORTHOPAEDIC WIRES. This device is classified as a Wire, Surgical (Class II - Special Controls, product code LRN).
Submitted by Acu Med, Inc. (Beaverton, US). The FDA issued a Cleared decision on November 9, 1994, 161 days after receiving the submission on June 1, 1994.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3030.
| 510(k) Number | K942603 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 01, 1994 |
| Decision Date | November 09, 1994 |
| Days to Decision | 161 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Statement |
| Product Code | LRN — Wire, Surgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3030 |