The following data is part of a premarket notification filed by Unicare Medical Products, Inc. with the FDA for Unicare Breast Shells.
| Device ID | K861608 |
| 510k Number | K861608 |
| Device Name: | UNICARE BREAST SHELLS |
| Classification | Shield, Nipple |
| Applicant | UNICARE MEDICAL PRODUCTS, INC. 119 MONTEE DE LIESSE, MONTREAL Quebec H4t 1s6, CA |
| Product Code | HFS |
| CFR Regulation Number | 880.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-04-29 |
| Decision Date | 1986-07-15 |