K891686 is an FDA 510(k) clearance for the LIB SYSTEM, BABY/ADULT DIAPER. 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 May 31, 1989, 70 days after receiving the submission on March 22, 1989.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5920.
| 510(k) Number | K891686 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 22, 1989 |
| Decision Date | May 31, 1989 |
| Days to Decision | 70 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 |