The following data is part of a premarket notification filed by O'donnell, Byrne & Williams with the FDA for Breast Shell.
| Device ID | K944177 |
| 510k Number | K944177 |
| Device Name: | BREAST SHELL |
| Classification | Shield, Nipple |
| Applicant | O'DONNELL, BYRNE & WILLIAMS 20 NORTH WACKER DR. SUITE 3710 Chicago, IL 60606 |
| Contact | Kevin Williams |
| Correspondent | Kevin Williams O'DONNELL, BYRNE & WILLIAMS 20 NORTH WACKER DR. SUITE 3710 Chicago, IL 60606 |
| Product Code | HFS |
| CFR Regulation Number | 880.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-26 |
| Decision Date | 1994-10-05 |