Submission Details
| 510(k) Number | K812779 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 05, 1981 |
| Decision Date | October 26, 1981 |
| Days to Decision | 21 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | — |
K812779 is an FDA 510(k) clearance for the EXTENSIONS-LUSATZTISCH, a Apparatus, Traction, Non-powered (Class I — General Controls, product code HST), submitted by The Telos Co. (Walker, US). The FDA issued a Cleared decision on October 26, 1981, 21 days after receiving the submission on October 5, 1981. This device falls under the Neurology review panel. Regulated under 21 CFR 888.5850.
| 510(k) Number | K812779 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 05, 1981 |
| Decision Date | October 26, 1981 |
| Days to Decision | 21 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | — |
| Product Code | HST — Apparatus, Traction, Non-powered |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 888.5850 |