Submission Details
| 510(k) Number | K853016 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 17, 1985 |
| Decision Date | August 07, 1985 |
| Days to Decision | 21 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | — |
K853016 is an FDA 510(k) clearance for the STILLE ANGULAR RONGEUR, 8-3/4 SS 410, submitted by The Huxley Instrument Corp. (Penn Yan, US). The FDA issued a Cleared decision on August 7, 1985, 21 days after receiving the submission on July 17, 1985. This device falls under the Dental review panel.
| 510(k) Number | K853016 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 17, 1985 |
| Decision Date | August 07, 1985 |
| Days to Decision | 21 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | — |
| Product Code | — |
| Device Class | — |