K770558 is an FDA 510(k) clearance for the ISODYNE. This device is classified as a Spring, Orthodontic (Class I - General Controls, product code ECO).
Submitted by Hmw Industries (Mchenry, US). The FDA issued a Cleared decision on April 5, 1977, 14 days after receiving the submission on March 22, 1977.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.5410.
| 510(k) Number | K770558 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 22, 1977 |
| Decision Date | April 05, 1977 |
| Days to Decision | 14 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | — |
| Product Code | ECO — Spring, Orthodontic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.5410 |