K823536 is an FDA 510(k) clearance for the INTRALIG. This device is classified as a Syringe, Cartridge (Class II - Special Controls, product code EJI).
Submitted by Miltex Instrument Co. (Mchenry, US). The FDA issued a Cleared decision on December 28, 1982, 28 days after receiving the submission on November 30, 1982.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6770.
| 510(k) Number | K823536 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 30, 1982 |
| Decision Date | December 28, 1982 |
| Days to Decision | 28 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | — |
| Product Code | EJI — Syringe, Cartridge |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.6770 |