K851789 is an FDA 510(k) clearance for the 29-200 TO 29-230 VARIOUS BONE MALLETS(WIHIGER, DOY. This device is classified as a Mallet, Surgical, General & Plastic Surgery (Class I - General Controls, product code GFJ).
Submitted by Artiberia (San Antonio, US). The FDA issued a Cleared decision on June 20, 1985, 56 days after receiving the submission on April 25, 1985.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K851789 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 25, 1985 |
| Decision Date | June 20, 1985 |
| Days to Decision | 56 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | GFJ — Mallet, Surgical, General & Plastic Surgery |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4800 |