K880859 is an FDA 510(k) clearance for the SURGICAL BURS. This device is classified as a Bur, Surgical, General & Plastic Surgery (Class I - General Controls, product code GFF).
Submitted by New England Surgical Instrument Corp. (Rockland, US). The FDA issued a Cleared decision on March 21, 1988, 20 days after receiving the submission on March 1, 1988.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4820.
| 510(k) Number | K880859 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 01, 1988 |
| Decision Date | March 21, 1988 |
| Days to Decision | 20 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | GFF — Bur, Surgical, General & Plastic Surgery |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4820 |