Laurier Sanitary Napkin
FDA 510(k) K882768 · Kao Corp.
510(k) numberK882768
Submission
- Device name
- Laurier Sanitary Napkin
- Applicant
- Kao Corp.
Tokyo 103 Japan, JP - Received
- July 6, 1988
- Decision date
- August 5, 1988
- 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 |
|---|---|---|
| K893773 | Laurier Sanitary NapkinHHD · Traditional | 08/11/1989SE |
| K872481 | Laurier Night Safe Extra Protection Sanitary Nap.HHD · Traditional | 08/05/1987SE |
| K862269 | Laurier Santary Napkin (Modification)HHD · Traditional | 07/30/1986SE |
| K862271 | Laurier Safety Long Sanitary Napkin (Modification)HHD · Traditional | 07/07/1986SE |
| K862270 | Laurier Overnight Sanitary Napkin (Modification)HHD · Traditional | 07/07/1986SE |
| K852924 | Laurier Safety Long Sanitory NapkinHHD · Traditional | 08/27/1985SE |
| K852922 | Laurier Overnight Sanitary NapkinHHD · Traditional | 08/26/1985SE |
| K843318 | Laurier Sanitary NapkinHHD · Traditional | 10/15/1984SE |
Questions and answers
When was Laurier Sanitary Napkin cleared by the FDA?
Laurier Sanitary Napkin (K882768) received a 510(k) decision of Substantially Equivalent on August 5, 1988, 30 days after the submission was received.
What is the product code of K882768?
The FDA product code is HHD – Pad, Menstrual, Unscented, a Class I (low risk) device regulated under 21 CFR 884.5435.