K932319 is an FDA 510(k) clearance for the ORTHODONTIC ELASTOMER. This device is classified as a Band, Elastic, Orthodontic (Class I - General Controls, product code ECI).
Submitted by Gac Intl., Inc. (Central Islip, US). The FDA issued a Cleared decision on September 20, 1993, 132 days after receiving the submission on May 11, 1993.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.5410.
| 510(k) Number | K932319 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 11, 1993 |
| Decision Date | September 20, 1993 |
| Days to Decision | 132 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | ECI — Band, Elastic, Orthodontic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.5410 |