HFS — Shield, Nipple Class I
FDA product code HFS covers "Shield, Nipple", a Class I medical device regulated under 21 CFR 880.5630. Submissions are reviewed by the General Hospital panel. At least 12 recent 510(k) clearances have been granted under this product code.
Classification details
- Product Code
- HFS
- Device Class
- Class I
- Regulation Number
- 880.5630
- Submission Type
- 510(k) Exempt
- Review Panel
- HO
- Medical Specialty
- General Hospital
- Implant
- No
Recent 510(k) clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K944177 | O'donnell, Byrne And Williams | BREAST SHELL | Oct 5, 1994 |
| K944117 | Avent America | AVENT NIPPLE SHIELD | Oct 5, 1994 |
| K935341 | Marshall Baby Products | COMFORT PLUS BREAST SHELLS | Jan 21, 1994 |
| K935340 | Marshall Baby Products | COMFORT PLUS NIPPLE SHIELDS | Jan 21, 1994 |
| K930238 | Prolac | BREAST LEAKAGE INHIBITOR SYSTEM: BREAST SHIELDS | Aug 16, 1993 |
| K923577 | Medela | BREAST SHELLS | Jan 22, 1993 |
| K864176 | Mali | GENTLE FEEL | Nov 4, 1986 |
| K861608 | Unicare Medical Products | UNICARE BREAST SHELLS | Jul 15, 1986 |
| K853176 | Medela | CANNON BABYSAFE NIPPLE SHIELDS | Aug 22, 1985 |
| K840877 | Sherwood Medical | ARGYLE ENTERNAL FEEDING BAG W/ADMIN | Jun 28, 1984 |
| K833450 | Reliance Products | NUK BREAST SHIELD | Nov 21, 1983 |
| K811364 | Neonatal | AXICARE BREAST SHELL | Aug 3, 1981 |