Submission Details
| 510(k) Number | K790561 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 19, 1979 |
| Decision Date | April 03, 1979 |
| Days to Decision | 15 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | — |
K790561 is an FDA 510(k) clearance for the OFFSET ALUMINUM CANE, a Cane (Class I — General Controls, product code IPS), submitted by Maddak, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 3, 1979, 15 days after receiving the submission on March 19, 1979. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.3075.
| 510(k) Number | K790561 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 19, 1979 |
| Decision Date | April 03, 1979 |
| Days to Decision | 15 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | — |
| Product Code | IPS — Cane |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 890.3075 |