K880028 is an FDA 510(k) clearance for the OMED DISPOSABLE SCALPEL. This device is classified as a Scalpel, One-piece (Class I - General Controls, product code GDX).
Submitted by Oxboro Medical Intl., Inc. (Bloomington, US). The FDA issued a Cleared decision on January 29, 1988, 24 days after receiving the submission on January 5, 1988.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K880028 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 05, 1988 |
| Decision Date | January 29, 1988 |
| Days to Decision | 24 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | GDX — Scalpel, One-piece |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4800 |