Submission Details
| 510(k) Number | K872121 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 27, 1987 |
| Decision Date | August 12, 1987 |
| Days to Decision | 77 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | — |
K872121 is an FDA 510(k) clearance for the K AND D HOME TRACT, a Apparatus, Traction, Non-powered (Class I — General Controls, product code HST), submitted by Joseph A. Kott, M.D. (Metairie, US). The FDA issued a Cleared decision on August 12, 1987, 77 days after receiving the submission on May 27, 1987. This device falls under the Neurology review panel. Regulated under 21 CFR 888.5850.
| 510(k) Number | K872121 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 27, 1987 |
| Decision Date | August 12, 1987 |
| Days to Decision | 77 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 |