K800647 is an FDA 510(k) clearance for the NORSEN DEBRIDER. This device is classified as a Forceps, General & Plastic Surgery (Class I - General Controls, product code GEN).
Submitted by Medline Industries, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 16, 1980, 23 days after receiving the submission on March 24, 1980.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K800647 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 24, 1980 |
| Decision Date | April 16, 1980 |
| Days to Decision | 23 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | GEN — Forceps, General & Plastic Surgery |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4800 |