UNICARE BREAST SHELLS
Device Facts
| Record ID | K861608 |
|---|---|
| Device Name | UNICARE BREAST SHELLS |
| Applicant | Unicare Medical Products, Inc. |
| Product Code | HFS · General Hospital |
| Decision Date | Jul 15, 1986 |
| 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.
