K812344 is an FDA 510(k) clearance for the HEEL OR ELBOW PROTECTOR. This device is classified as a Protector, Skin Pressure (Class I - General Controls, product code FMP).
Submitted by Fred Sammons, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 11, 1981, 24 days after receiving the submission on August 18, 1981.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6450.
| 510(k) Number | K812344 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 18, 1981 |
| Decision Date | September 11, 1981 |
| Days to Decision | 24 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 |