K854888 is an FDA 510(k) clearance for the RANDALL CURETTE. This device is classified as a Curette, Surgical, General Use (Class I - General Controls, product code FZS).
Submitted by Euro-Med Intl. (Danville, US). The FDA issued a Cleared decision on December 24, 1985, 18 days after receiving the submission on December 6, 1985.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K854888 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 06, 1985 |
| Decision Date | December 24, 1985 |
| Days to Decision | 18 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | FZS — Curette, Surgical, General Use |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4800 |