K842627 is an FDA 510(k) clearance for the C-SECTION TRAY. This device is classified as a Kit, Surgical Instrument, Disposable (Class I - General Controls, product code KDD).
Submitted by Deroyal Industries, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 26, 1984, 82 days after receiving the submission on July 6, 1984.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K842627 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 06, 1984 |
| Decision Date | September 26, 1984 |
| Days to Decision | 82 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | KDD — Kit, Surgical Instrument, Disposable |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4800 |