Unicare Breast Shells
FDA 510(k) K861608 · Unicare Medical Products, Inc.
510(k) numberK861608
Submission
- Device name
- Unicare Breast Shells
- Applicant
- Unicare Medical Products, Inc.
Quebec H4t 1s6, CA - Received
- April 29, 1986
- Decision date
- July 15, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HFS – Shield, Nipple
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 880.5630
- Specialty
- General Hospital
Other 510(k)s with product code HFS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K944177 | Breast ShellHFS · Traditional | O'Donnell, Byrne & Williams | 10/05/1994SE |
| K944117 | Avent Nipple ShieldHFS · Traditional | Avent America, Inc. | 10/05/1994SE |
| K935341 | Comfort Plus Breast ShellsHFS · Traditional | Marshall Baby Products | 01/21/1994SE |
| K935340 | Comfort Plus Nipple ShieldsHFS · Traditional | Marshall Baby Products | 01/21/1994SE |
| K930238 | Breast Leakage Inhibitor System: Breast ShieldsHFS · Traditional | Prolac, Inc. | 08/16/1993SE |
| K923577 | Breast ShellsHFS · Traditional | Medela, Inc. | 01/22/1993SE |
| K864176 | Gentle FeelHFS · Traditional | Mali, Inc. | 11/04/1986SE |
| K853176 | Cannon Babysafe Nipple ShieldsHFS · Traditional | Medela, Inc. | 08/22/1985SE |
| K840877 | Argyle Enternal Feeding Bag W/AdminHFS · Traditional | Sherwood Medical Co. | 06/28/1984SE |
| K833450 | Nuk Breast ShieldHFS · Traditional | Reliance Products Corp. | 11/21/1983SE |
Questions and answers
When was Unicare Breast Shells cleared by the FDA?
Unicare Breast Shells (K861608) received a 510(k) decision of Substantially Equivalent on July 15, 1986, 77 days after the submission was received.
What is the product code of K861608?
The FDA product code is HFS – Shield, Nipple, a Class I (low risk) device regulated under 21 CFR 880.5630.