Stayfree(Tm) Maxi-Pad
FDA 510(k) K913747 · Personal Products Co.
510(k) numberK913747
Submission
- Device name
- Stayfree(Tm) Maxi-Pad
- Applicant
- Personal Products Co.
Milltown, NJ, US - Received
- August 21, 1991
- Decision date
- November 5, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
|---|---|---|
| K070545 | K-Y Brand Warming LiquidNUC · Special | 03/23/2007SE |
| K062796 | K-Y Brand IntrigueNUC · Traditional | 12/08/2006SE |
| K010365 | Ortho Control Female Urinary Control DeviceMNG · Traditional | 04/30/2001SE |
| K990536 | O.B. TamponHEB · Traditional | 08/31/1999SE |
| K991118 | O.B. Applicator Tampons, O.B. TamponsHEB · Traditional | 06/29/1999SE |
| K974629 | O.B. Applicator and Non-Applicator TamponsHEB · Traditional | 02/10/1998SE |
| K971589 | Reach Antibacterial ToothbrushEFW · Traditional | 07/24/1997SE |
| K970954 | O.B. Applicator TamponsHEB · Traditional | 06/10/1997SE |
| K961119 | Carefree PantylinersHHL · Traditional | 04/17/1996SE |
| K953638 | O.B. Applicator TamponsHIL · Traditional | 10/20/1995SE |
Questions and answers
When was Stayfree(Tm) Maxi-Pad cleared by the FDA?
Stayfree(Tm) Maxi-Pad (K913747) received a 510(k) decision of Substantially Equivalent on November 5, 1991, 76 days after the submission was received.
What is the product code of K913747?
The FDA product code is HHD – Pad, Menstrual, Unscented, a Class I (low risk) device regulated under 21 CFR 884.5435.