Satin Touch Deodorant Tampon Junior, Regular, Super, Super Plus
FDA 510(k) K952344 · Tambrands, Inc.
510(k) numberK952344
Submission
- Device name
- Satin Touch Deodorant Tampon Junior, Regular, Super, Super Plus
- Applicant
- Tambrands, Inc.
White Plains, NY, US - Received
- May 19, 1995
- Decision date
- July 28, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HIL – Tampon, Menstrual, Scented, Scented-Deodorized
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.5460
- Specialty
- Obstetrics/Gynecology
A scented or scented-deodorized menstrual tampon is a plug made of cellulosic or synthetic material that is inserted into the vagina and used to absorb menstrual fluid or other vaginal discharge.
Other 510(k)s with product code HIL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K132208 | Ontex and Others Proprietary NamesHIL · Traditional | Ontex Bvba | 04/10/2014SE |
| K132819 | Playtex (Scented and Unscented) Sport Fresh Balance TamponsHIL · Special | Playtex Manufacturing, Inc. | 10/09/2013SE |
| K120245 | Playtex Gentle Glide Scented Tampons and Playtex Gentle Glide Unscented TamponsHIL · Traditional | Playtex, Inc. | 06/21/2012SE |
| K111684 | Playtex Sport (Unscented) ,(Scented) with OdorshieldHIL · Traditional | Playtex Manufacturing, Inc. | 02/03/2012SE |
| K081555 | Tampax Pearl Plastic Applicator Tampons, Scented and UnscentedHIL · Special | Procter & Gamble Co. | 06/27/2008SE |
| K073662 | Playtex Gentile Glide, Playtex Gentile Glide Multipack TamponsHIL · Special | Playtex Products, Inc. | 01/17/2008SE |
| K072376 | Playtex Gentle Glide, Playtex Gentle Glide Multipack TamponsHIL · Traditional | Playtex Products, Inc. | 12/12/2007SE |
| K070745 | Modification to: Playtex Gentle Glide Plastic, Playtex Gentle Plastic Multipack TamponsHIL · Special | Playtex Products, Inc. | 04/13/2007SE |
| K060981 | Playtex Sport Plastic, Playtex Sport Plastic Multipack TamponsHIL · Special | Playtex Products, Inc. | 05/09/2006SE |
| K051446 | Femtex and Private Label Opal Fresh Scented Plastic Applicator TamponsHIL · Traditional | First Quality Hygienic, Inc. | 07/14/2005SE |
More from First Quality Hygienic, 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 |
| 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 |
| K896112 | Tampax Tampon, Flushable Applicator, Super PlusHEB · Traditional | 12/13/1989SE |
Questions and answers
When was Satin Touch Deodorant Tampon Junior, Regular, Super, Super Plus cleared by the FDA?
Satin Touch Deodorant Tampon Junior, Regular, Super, Super Plus (K952344) received a 510(k) decision of Substantially Equivalent on July 28, 1995, 70 days after the submission was received.
What is the product code of K952344?
The FDA product code is HIL – Tampon, Menstrual, Scented, Scented-Deodorized, a Class II (moderate risk) device regulated under 21 CFR 884.5460.