FDA Product Code
FDA Product Code HFS — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- General Hospital
- 21 CFR Citation
- 880.5630
510(k) Clearances — 12 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K944117 | AVENT NIPPLE SHIELD | Avent America, Inc. | 1994-10-05 | Traditional | PDF ↗ |
| K944177 | BREAST SHELL | O'Donnell, Byrne & Williams | 1994-10-05 | Traditional | PDF ↗ |
| K935341 | COMFORT PLUS BREAST SHELLS | Marshall Baby Products | 1994-01-21 | Traditional | PDF ↗ |
| K935340 | COMFORT PLUS NIPPLE SHIELDS | Marshall Baby Products | 1994-01-21 | Traditional | PDF ↗ |
| K930238 | BREAST LEAKAGE INHIBITOR SYSTEM: BREAST SHIELDS | Prolac, Inc. | 1993-08-16 | Traditional | PDF ↗ |
| K923577 | BREAST SHELLS | Medela, Inc. | 1993-01-22 | Traditional | PDF ↗ |
| K864176 | GENTLE FEEL | Mali, Inc. | 1986-11-04 | Traditional | PDF ↗ |
| K861608 | UNICARE BREAST SHELLS | Unicare Medical Products, Inc. | 1986-07-15 | Traditional | PDF ↗ |
| K853176 | CANNON BABYSAFE NIPPLE SHIELDS | Medela, Inc. | 1985-08-22 | Traditional | PDF ↗ |
| K840877 | ARGYLE ENTERNAL FEEDING BAG W/ADMIN | Sherwood Medical Co. | 1984-06-28 | Traditional | PDF ↗ |
| K833450 | NUK BREAST SHIELD | Reliance Products Corp. | 1983-11-21 | Traditional | PDF ↗ |
| K811364 | AXICARE BREAST SHELL | Neonatal Corp. | 1981-08-03 | Traditional | PDF ↗ |
Product code HFS · Class I · General Hospital. Data: openFDA.