The following data is part of a premarket notification filed by Avent America, Inc. with the FDA for Avent Nipple Shield.
| Device ID | K944117 |
| 510k Number | K944117 |
| Device Name: | AVENT NIPPLE SHIELD |
| Classification | Shield, Nipple |
| Applicant | AVENT AMERICA, INC. 1765 W. CORTLAND COURT, UNIT L Addison, IL 60101 |
| Product Code | HFS |
| CFR Regulation Number | 880.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-23 |
| Decision Date | 1994-10-05 |