K781351 is an FDA 510(k) clearance for the AURO-BRUSH..
Submitted by Parker Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 4, 1978, 119 days after receiving the submission on August 7, 1978.
This device falls under the Dental FDA review panel.
| 510(k) Number | K781351 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 07, 1978 |
| Decision Date | December 04, 1978 |
| Days to Decision | 119 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | — |
| Product Code | — |
| Device Class | — |