K832068 is an FDA 510(k) clearance for the CODY SACCULOTOMY TACK. This device is classified as a Tack, Sacculotomy (cody Tack) (Class II - Special Controls, product code ESX).
Submitted by Micromedics, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 19, 1983, 114 days after receiving the submission on June 27, 1983.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.3760.
| 510(k) Number | K832068 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 27, 1983 |
| Decision Date | October 19, 1983 |
| Days to Decision | 114 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | — |
| Product Code | ESX — Tack, Sacculotomy (cody Tack) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 874.3760 |