K941858 is an FDA 510(k) clearance for the GEL CUSHION. This device is classified as a Cushion, Flotation (Class I — General Controls, product code KIC).
Submitted by Hollister, Inc. (Libertyville, US). The FDA issued a Cleared decision on May 5, 1994, 20 days after receiving the submission on April 15, 1994.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3175.
| 510(k) Number | K941858 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 15, 1994 |
| Decision Date | May 05, 1994 |
| Days to Decision | 20 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Statement |
| Product Code | KIC — Cushion, Flotation |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 890.3175 |