K852599 is an FDA 510(k) clearance for the A-COMPANY ELASTOMERIC TUBING. This device is classified as a Band, Elastic, Orthodontic (Class I - General Controls, product code ECI).
Submitted by A Company, Inc. (San Diego, US). The FDA issued a Cleared decision on July 31, 1985, 42 days after receiving the submission on June 19, 1985.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.5410.
| 510(k) Number | K852599 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 19, 1985 |
| Decision Date | July 31, 1985 |
| Days to Decision | 42 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | — |
| Product Code | ECI — Band, Elastic, Orthodontic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.5410 |