SAFTE ORIONE HERNIA BELT ITEMS NO. 316, 515, 536
Device Facts
| Record ID | K901922 |
|---|---|
| Device Name | SAFTE ORIONE HERNIA BELT ITEMS NO. 316, 515, 536 |
| Applicant | Safte S.P.A. |
| Product Code | EXN · Gastroenterology, Urology |
| Decision Date | Oct 26, 1990 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 876.5970 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A hernia support is a device, usually made of elastic, canvas, leather, or metal, that is intended to be placed over a hernial opening (a weakness in the abdominal wall) to prevent protrusion of the abdominal contents. This generic type of device includes the umbilical truss.
