K862380 is an FDA 510(k) clearance for the MATTRESS COVER. This device is classified as a Garment, Protective, For Incontinence (Class I - General Controls, product code EYQ).
Submitted by Intera Corp. (Chattanooga, US). The FDA issued a Cleared decision on July 28, 1986, 34 days after receiving the submission on June 24, 1986.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5920.
| 510(k) Number | K862380 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 24, 1986 |
| Decision Date | July 28, 1986 |
| Days to Decision | 34 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
| Product Code | EYQ — Garment, Protective, For Incontinence |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 876.5920 |