AMEDA HYGIENIKIT
Device Facts
| Record ID | K011519 |
|---|---|
| Device Name | AMEDA HYGIENIKIT |
| Applicant | Hollister, Inc. |
| Product Code | HGY · Obstetrics/Gynecology |
| Decision Date | Aug 15, 2001 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 884.5150 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A nonpowered breast pump is a manual suction device used to express milk from the breast.
