K861196 is an FDA 510(k) clearance for the STERILE STOCKINETTE W/ANTIMICROBIAL AGENT. This device is classified as a Drape, Surgical (Class II - Special Controls, product code KKX).
Submitted by Deroyal Industries, Inc. (Powell, US). The FDA issued a Cleared decision on April 30, 1986, 30 days after receiving the submission on March 31, 1986.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4370.
| 510(k) Number | K861196 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 31, 1986 |
| Decision Date | April 30, 1986 |
| Days to Decision | 30 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | KKX — Drape, Surgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4370 |