AXICARE BREAST SHELL
Device Facts
| Record ID | K811364 |
|---|---|
| Device Name | AXICARE BREAST SHELL |
| Applicant | Neonatal Corp. |
| Product Code | HFS · General Hospital |
| Decision Date | Aug 3, 1981 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.5630 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A nipple shield is a device consisting of a cover used to protect the nipple of a nursing woman. This generic device does not include nursing pads intended solely to protect the clothing of a nursing woman from milk.
