K941349 is an FDA 510(k) clearance for the DENTAL TRAY. This device is classified as a Unit, Operative Dental (Class I - General Controls, product code EIA).
Submitted by Cush Medical Products (Piney Flats, US). The FDA issued a Cleared decision on July 26, 1994, 127 days after receiving the submission on March 21, 1994.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6640.
| 510(k) Number | K941349 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - NSE Converted (SN) |
| Date Received | March 21, 1994 |
| Decision Date | July 26, 1994 |
| Days to Decision | 127 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | — |
| Product Code | EIA — Unit, Operative Dental |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.6640 |