K830360 is an FDA 510(k) clearance for the 3M OSTEOTOMY GUIDE. This device is classified as a Template (Class I - General Controls, product code HWT).
Submitted by 3M Company (White City, US). The FDA issued a Cleared decision on March 1, 1983, 26 days after receiving the submission on February 3, 1983.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.4800.
| 510(k) Number | K830360 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 03, 1983 |
| Decision Date | March 01, 1983 |
| Days to Decision | 26 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | — |
| Product Code | HWT — Template |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 888.4800 |