K893809 is an FDA 510(k) clearance for the COUGH PILLOW. This device is classified as a Binder, Elastic (Class I — General Controls, product code KMO).
Submitted by Custom Hospitals Products (Portland, US). The FDA issued a Cleared decision on August 28, 1989, 98 days after receiving the submission on May 22, 1989.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5160.
| 510(k) Number | K893809 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 22, 1989 |
| Decision Date | August 28, 1989 |
| Days to Decision | 98 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | KMO — Binder, Elastic |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 880.5160 |