Hospital Tabbed Napkins Super Belted Feminine Napk
FDA 510(k) K860294 · I.C.D. Industries, Inc.
510(k) numberK860294
Submission
- Device name
- Hospital Tabbed Napkins Super Belted Feminine Napk
- Applicant
- I.C.D. Industries, Inc.
King Of Prussia, PA, US - Received
- January 28, 1986
- Decision date
- March 13, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HHD – Pad, Menstrual, Unscented
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 884.5435
- Specialty
- Obstetrics/Gynecology
An unscented menstrual pad which is used to absorb menstrual fluid or other vaginal discharge and is made of common cellulosic and synthetic material with an established safety profile.
Other 510(k)s with product code HHD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K071827 | Always Menstrual PadsHHD · Traditional | Procter & Gamble, Inc. | 09/20/2007SE |
| K012629 | Always DuetsHHD · Traditional | Procter & Gamble Co. | 10/05/2001SE |
| K003843 | Envive MiniformsHHD · Traditional | Procter & Gamble Co. | 02/08/2001SE |
| K993870 | Unscented Interlabial Menstrual PadHHD · Traditional | Procter & Gamble Co. | 01/18/2000SE |
| K980395 | Gladrags Cotton Menstrual PadHHD · Traditional | Keepers!, Inc. | 04/16/1998SE |
| K953470 | Flushies Flushable/Biodegradable Menstrual Pads/Napkins (Ultra Thins)HHD · Traditional | Mediquip, Inc. | 11/21/1995SE |
| K953668 | Unscented Ultrathin Maxi PadHHD · Traditional | Paragon Trade Brands, Inc. | 11/01/1995SE |
| K953667 | Unscented Curved Ultrathin Maxi PadsHHD · Traditional | Paragon Trade Brands, Inc. | 11/01/1995SE |
| K953633 | Unscented Menstrual PadHHD · Traditional | Tendasoft, Inc. | 11/01/1995SE |
| K953553 | Unscented Menstral PadHHD · Traditional | Paragon Trade Brands, Inc. | 10/27/1995SE |
More from Paragon Trade Brands, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K853079 | Protective Pad for IncontinenceEYQ · Traditional | 08/09/1985SE |
| K844975 | Scented Breathable Mini-Shield Private Label BrandHHL · Traditional | 02/25/1985SE |
| K843886 | Scented Breathable Private Label Mini-ShHHL · Traditional | 10/25/1984SE |
| 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 Hospital Tabbed Napkins Super Belted Feminine Napk cleared by the FDA?
Hospital Tabbed Napkins Super Belted Feminine Napk (K860294) received a 510(k) decision of Substantially Equivalent on March 13, 1986, 44 days after the submission was received.
What is the product code of K860294?
The FDA product code is HHD – Pad, Menstrual, Unscented, a Class I (low risk) device regulated under 21 CFR 884.5435.