Submission Details
| 510(k) Number | K770346 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 22, 1977 |
| Decision Date | March 07, 1977 |
| Days to Decision | 13 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | — |
K770346 is an FDA 510(k) clearance for the ORTHOPEDIC STOCKINETTE, a Stocking, Elastic (Class I — General Controls, product code ILG), submitted by Convertors (Mchenry, US). The FDA issued a Cleared decision on March 7, 1977, 13 days after receiving the submission on February 22, 1977. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.3475.
| 510(k) Number | K770346 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 22, 1977 |
| Decision Date | March 07, 1977 |
| Days to Decision | 13 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | — |
| Product Code | ILG — Stocking, Elastic |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 890.3475 |