Submission Details
| 510(k) Number | K823413 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 15, 1982 |
| Decision Date | March 29, 1983 |
| Days to Decision | 134 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | — |
K823413 is an FDA 510(k) clearance for the MOUTH CARE KIT W/TOOTHBRUSH, submitted by Sage Products, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 29, 1983, 134 days after receiving the submission on November 15, 1982. This device falls under the Dental review panel.
| 510(k) Number | K823413 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 15, 1982 |
| Decision Date | March 29, 1983 |
| Days to Decision | 134 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | — |
| Product Code | — |
| Device Class | — |