K973679 is an FDA 510(k) clearance for the AEROETCHER. This device is classified as a Airbrush (Class II - Special Controls, product code KOJ).
Submitted by Parkell, Inc. (Farmingdale, US). The FDA issued a Cleared decision on March 10, 1998, 165 days after receiving the submission on September 26, 1997.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6080.
| 510(k) Number | K973679 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 26, 1997 |
| Decision Date | March 10, 1998 |
| Days to Decision | 165 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | KOJ — Airbrush |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.6080 |