CARAPACE STERILE COTTON BALLS
Device Facts
| Record ID | K931626 |
|---|---|
| Device Name | CARAPACE STERILE COTTON BALLS |
| Applicant | Carapace, Inc. |
| Product Code | FRL · General Hospital |
| Decision Date | Dec 2, 1993 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.5300 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A medical absorbent fiber is a device intended for medical purposes that is made from cotton or synthetic fiber in the shape of a ball or a pad and that is used for applying medication to, or absorbing small amounts of body fluids from, a patient's body surface. Absorbent fibers intended solely for cosmetic purposes are not included in this generic device category.
