Submission Details
| 510(k) Number | K852718 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 26, 1985 |
| Decision Date | July 15, 1985 |
| Days to Decision | 19 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | — |
K852718 is an FDA 510(k) clearance for the ADSON TISSUE FORCEPS, 1X2 TEETH 4-3/4+SS, a Forceps (Class I — General Controls, product code HTD), submitted by The Huxley Instrument Corp. (Penn Yan, US). The FDA issued a Cleared decision on July 15, 1985, 19 days after receiving the submission on June 26, 1985. This device falls under the Immunology review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K852718 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 26, 1985 |
| Decision Date | July 15, 1985 |
| Days to Decision | 19 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | — |
| Product Code | HTD — Forceps |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 878.4800 |