K802781 is an FDA 510(k) clearance for the BEDDING PADS EGGCREATE PADS. This device is classified as a Mattress, Flotation Therapy, Non-powered (Class I - General Controls, product code IKY).
Submitted by Leemart Bedding Mfg. Co. (Mchenry, US). The FDA issued a Cleared decision on December 10, 1980, 35 days after receiving the submission on November 5, 1980.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5150.
| 510(k) Number | K802781 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 05, 1980 |
| Decision Date | December 10, 1980 |
| Days to Decision | 35 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | IKY — Mattress, Flotation Therapy, Non-powered |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 880.5150 |