Tampax Ultrafit Panty Shields - Mofification
FDA 510(k) K891474 · Tambrands, Inc.
510(k) numberK891474
Submission
- Device name
- Tampax Ultrafit Panty Shields - Mofification
- Applicant
- Tambrands, Inc.
Palmer, MA, US - Received
- March 16, 1989
- Decision date
- June 7, 1989
- 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 |
|---|---|---|
| K962476 | Unscented Menstrual Tampon, Plastic ApplicatorHEB · Traditional | 08/13/1996SE |
| K960341 | Tampax Tampon with Additive Junior,Regular,Super, and Super PlusHEB · Traditional | 04/17/1996SE |
| K952344 | Satin Touch Deodorant Tampon Junior, Regular, Super, Super PlusHIL · Traditional | 07/28/1995SE |
| K944834 | Unscented Menstrual TamponsHEB · Traditional | 12/21/1994SE |
| K924303 | Tampax Tampon, Regular AbsorbencyHEB · Traditional | 07/29/1993SE |
| K923932 | Tampax Tampons, Super AbsorbencyHEB · Traditional | 07/29/1993SE |
| K896989 | Tampax TamponHEB · Traditional | 12/22/1989SE |
| K896115 | Tampon, Petal Soft Plastic Appli., Deodorant SuperHIL · Traditional | 12/13/1989SE |
| K896114 | Tampon, Petal Soft Plastic Appli., Super Absorb.HEB · Traditional | 12/13/1989SE |
| K896113 | Tampon, Petal Soft Plastic Applicator, Super PlusHEB · Traditional | 12/13/1989SE |
Questions and answers
When was Tampax Ultrafit Panty Shields - Mofification cleared by the FDA?
Tampax Ultrafit Panty Shields - Mofification (K891474) received a 510(k) decision of Substantially Equivalent on June 7, 1989, 83 days after the submission was received.
What is the product code of K891474?
The FDA product code is HHD – Pad, Menstrual, Unscented, a Class I (low risk) device regulated under 21 CFR 884.5435.