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
- Review Panel
- HO
- Medical Specialty
- General Hospital
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K944117 | avent america | AVENT NIPPLE SHIELD | October 5, 1994 |
| K944177 | o'donnell, byrne and williams | BREAST SHELL | October 5, 1994 |
| K935340 | marshall baby products | COMFORT PLUS NIPPLE SHIELDS | January 21, 1994 |
| K935341 | marshall baby products | COMFORT PLUS BREAST SHELLS | January 21, 1994 |
| K930238 | prolac | BREAST LEAKAGE INHIBITOR SYSTEM: BREAST SHIELDS | August 16, 1993 |
| K923577 | medela | BREAST SHELLS | January 22, 1993 |
| K864176 | mali | GENTLE FEEL | November 4, 1986 |
| K861608 | unicare medical products | UNICARE BREAST SHELLS | July 15, 1986 |
| K853176 | medela | CANNON BABYSAFE NIPPLE SHIELDS | August 22, 1985 |
| K840877 | sherwood medical | ARGYLE ENTERNAL FEEDING BAG W/ADMIN | June 28, 1984 |
| K833450 | reliance products | NUK BREAST SHIELD | November 21, 1983 |
| K811364 | neonatal | AXICARE BREAST SHELL | August 3, 1981 |