K924139 is an FDA 510(k) clearance for the GLENROE ORTHO SEPS. This device is classified as a Band, Elastic, Orthodontic (Class I - General Controls, product code ECI).
Submitted by Glenroe Technologies (Bradenton, US). The FDA issued a Cleared decision on April 8, 1993, 233 days after receiving the submission on August 18, 1992.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.5410.
| 510(k) Number | K924139 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 18, 1992 |
| Decision Date | April 08, 1993 |
| Days to Decision | 233 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 |