The following data is part of a premarket notification filed by Neonatal Corp. with the FDA for Axicare Breast Shell.
| Device ID | K811364 |
| 510k Number | K811364 |
| Device Name: | AXICARE BREAST SHELL |
| Classification | Shield, Nipple |
| Applicant | NEONATAL CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HFS |
| CFR Regulation Number | 880.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-05-14 |
| Decision Date | 1981-08-03 |