K884473 is an FDA 510(k) clearance for the RUBIN BONE PLANER W/REPLACEABLE BLADE. This device is classified as a Rasp, Surgical, General & Plastic Surgery (Class I - General Controls, product code GAC).
Submitted by Neo Contemporary Co. (Quincy, US). The FDA issued a Cleared decision on December 9, 1988, 45 days after receiving the submission on October 25, 1988.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K884473 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 25, 1988 |
| Decision Date | December 09, 1988 |
| Days to Decision | 45 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | GAC — Rasp, Surgical, General & Plastic Surgery |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4800 |