Submission Details
| 510(k) Number | K852717 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 | General & Plastic Surgery (SU) |
| Summary | — |
K852717 is an FDA 510(k) clearance for the IRIS FORCEPS, DELICATE, 1X2 TEETH, STRAIGHT, 4XSS, a Forceps, General & Plastic Surgery (Class I — General Controls, product code GEN), 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 General & Plastic Surgery review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K852717 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 | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | GEN — Forceps, General & Plastic Surgery |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 878.4800 |