K843206 is an FDA 510(k) clearance for the COOK COUNTY HOSPITAL DRESSING CHANGE SET. This device is classified as a Kit, Surgical Instrument, Disposable (Class I - General Controls, product code KDD).
Submitted by Geneva Laboratories, Inc. (Walker, US). The FDA issued a Cleared decision on May 24, 1985, 282 days after receiving the submission on August 15, 1984.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K843206 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 15, 1984 |
| Decision Date | May 24, 1985 |
| Days to Decision | 282 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 |