Scented Breathable Private Label Mini-Sh
FDA 510(k) K843886 · I.C.D. Industries, Inc.
510(k) numberK843886
Submission
- Device name
- Scented Breathable Private Label Mini-Sh
- Applicant
- I.C.D. Industries, Inc.
King Of Prussia, PA, US - Received
- October 2, 1984
- Decision date
- October 25, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HHL – Pad, Menstrual, Scented, Scented-Deodorized
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.5425
- Specialty
- Obstetrics/Gynecology
Scented or scented-deodorized menstrual pads used to absorb menstrual or other vaginal discharge, including those intended as intralabial pads or reusable menstrual pads. These are made with materials that do not meet the requirements for Class 1 per 21 CFR 884.5425(b).
Other 510(k)s with product code HHL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K962962 | Deodorant Panty LinerHHL · Traditional | Paragon Trade Brands, Inc. | 10/10/1996SE |
| K962954 | Deodorant Maxi PadHHL · Traditional | Paragon Trade Brands, Inc. | 10/10/1996SE |
| K962953 | Deodorant Panty ShieldHHL · Traditional | Paragon Trade Brands, Inc. | 10/10/1996SE |
| K961119 | Carefree PantylinersHHL · Traditional | Personal Products Co. | 04/17/1996SE |
| K913238 | Always, Unscented Menstrual PadHHL · Traditional | Procter & Gamble Co. | 09/23/1991SE |
| K913237 | Always, Scented/Scented Deodorized Menstrual PadHHL · Traditional | Procter & Gamble Co. | 09/23/1991SE |
| K891473 | Tampax Ultrafit Panty Shields/Dedorant-ModificatioHHL · Traditional | Tambrands, Inc. | 06/07/1989SE |
| K890655 | New Freedom Thin Deodorant Maxi PadsHHL · Traditional | Kimberly-Clark Corp. | 05/01/1989SE |
| K884951 | Tampax Ultrafit Panty Shields, DeodorantHHL · Traditional | Tambrands, Inc. | 01/10/1989SE |
| K884446 | Maxithins Super Pads, DeodorantHHL · Traditional | Tambrands, Inc. | 12/20/1988SE |
More from Tambrands, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K860294 | Hospital Tabbed Napkins Super Belted Feminine NapkHHD · Traditional | 03/13/1986SE |
| K853079 | Protective Pad for IncontinenceEYQ · Traditional | 08/09/1985SE |
| K844975 | Scented Breathable Mini-Shield Private Label BrandHHL · Traditional | 02/25/1985SE |
| K843602 | Breathable Mini-Shield-Private LabelHHD · Traditional | 10/05/1984SE |
| K820288 | Mini Shields Menstrual PadsHHD · Traditional | 03/05/1982SE |
| K820287 | Maxi Shields Menstrual PadsHHD · Traditional | 03/05/1982SE |
| K813252 | Unscented Menstrual Pads-Mini PadsHHD · Traditional | 12/14/1981SE |
| K813251 | Unscented Menstrual Pads-Maxi PadsHHD · Traditional | 12/14/1981SE |
Questions and answers
When was Scented Breathable Private Label Mini-Sh cleared by the FDA?
Scented Breathable Private Label Mini-Sh (K843886) received a 510(k) decision of Substantially Equivalent on October 25, 1984, 23 days after the submission was received.
What is the product code of K843886?
The FDA product code is HHL – Pad, Menstrual, Scented, Scented-Deodorized, a Class II (moderate risk) device regulated under 21 CFR 884.5425.