The following data is part of a premarket notification filed by Medela, Inc. with the FDA for Breast Shells.
| Device ID | K923577 |
| 510k Number | K923577 |
| Device Name: | BREAST SHELLS |
| Classification | Shield, Nipple |
| Applicant | MEDELA, INC. P.O. 660 Mchenry, IL 60051 |
| Contact | Stephen D Smith |
| Correspondent | Stephen D Smith MEDELA, INC. P.O. 660 Mchenry, IL 60051 |
| Product Code | HFS |
| CFR Regulation Number | 880.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-07-20 |
| Decision Date | 1993-01-22 |