K811184 is an FDA 510(k) clearance for the SPENCO DERMAL PADS. This device is classified as a Protector, Skin Pressure (Class I - General Controls, product code FMP).
Submitted by Spenco Medical Corp. (Mchenry, US). The FDA issued a Cleared decision on May 20, 1981, 21 days after receiving the submission on April 29, 1981.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6450.
| 510(k) Number | K811184 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 29, 1981 |
| Decision Date | May 20, 1981 |
| Days to Decision | 21 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | FMP — Protector, Skin Pressure |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 880.6450 |