Nuk Breast Shield
FDA 510(k) K833450 · Reliance Products Corp.
510(k) numberK833450
Submission
- Device name
- Nuk Breast Shield
- Applicant
- Reliance Products Corp.
Mchenry, IL, US - Received
- October 5, 1983
- Decision date
- November 21, 1983
- 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 |
| K861608 | Unicare Breast ShellsHFS · Traditional | Unicare Medical Products, Inc. | 07/15/1986SE |
| 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 |
Questions and answers
When was Nuk Breast Shield cleared by the FDA?
Nuk Breast Shield (K833450) received a 510(k) decision of Substantially Equivalent on November 21, 1983, 47 days after the submission was received.
What is the product code of K833450?
The FDA product code is HFS – Shield, Nipple, a Class I (low risk) device regulated under 21 CFR 880.5630.