K980672 is an FDA 510(k) clearance for the SIMPLEX AIRBRATOR (SAB-7). This device is classified as a Airbrush (Class II - Special Controls, product code KOJ).
Submitted by Irt Management Corp. (Hallandale, US). The FDA issued a Cleared decision on May 4, 2000, 804 days after receiving the submission on February 20, 1998.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6080.
| 510(k) Number | K980672 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 20, 1998 |
| Decision Date | May 04, 2000 |
| Days to Decision | 804 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | KOJ — Airbrush |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.6080 |