Gentle Feel
FDA 510(k) K864176 · Mali, Inc.
510(k) numberK864176
Submission
- Device name
- Gentle Feel
- Applicant
- Mali, Inc.
Tarzana, CA, US - Received
- October 24, 1986
- Decision date
- November 4, 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 |
| 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 |
| K833450 | Nuk Breast ShieldHFS · Traditional | Reliance Products Corp. | 11/21/1983SE |
More from Reliance Products Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K855209 | Nir Lat Male External CatheterKNX · Traditional | 01/10/1986SE |
Questions and answers
When was Gentle Feel cleared by the FDA?
Gentle Feel (K864176) received a 510(k) decision of Substantially Equivalent on November 4, 1986, 11 days after the submission was received.
What is the product code of K864176?
The FDA product code is HFS – Shield, Nipple, a Class I (low risk) device regulated under 21 CFR 880.5630.