K943334 is an FDA 510(k) clearance for the HAWLEY RETAINER ORTHODONTIC APPLICANCE KIT. This device is classified as a Wire, Orthodontic (Class I - General Controls, product code DZC).
Submitted by Jay H. Geller (Santa Monica, US). The FDA issued a Cleared decision on October 5, 1994, 85 days after receiving the submission on July 12, 1994.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.5410.
| 510(k) Number | K943334 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 12, 1994 |
| Decision Date | October 05, 1994 |
| Days to Decision | 85 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | DZC — Wire, Orthodontic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.5410 |