K841247 is an FDA 510(k) clearance for the SPC DISPOSABLE CUTTER. This device is classified as a Cutter, Surgical (Class I - General Controls, product code FZT).
Submitted by Surgical Products Corp. (Mchenry, US). The FDA issued a Cleared decision on May 2, 1984, 42 days after receiving the submission on March 21, 1984.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K841247 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 21, 1984 |
| Decision Date | May 02, 1984 |
| Days to Decision | 42 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | FZT — Cutter, Surgical |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4800 |