Submission Details
| 510(k) Number | K812475 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 31, 1981 |
| Decision Date | September 14, 1981 |
| Days to Decision | 14 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | — |
K812475 is an FDA 510(k) clearance for the TRANSFER BENCH, a Aid, Transfer (Class I — General Controls, product code IKX), submitted by Maddak, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 14, 1981, 14 days after receiving the submission on August 31, 1981. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5050.
| 510(k) Number | K812475 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 31, 1981 |
| Decision Date | September 14, 1981 |
| Days to Decision | 14 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | — |
| Product Code | IKX — Aid, Transfer |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 890.5050 |