Tampax Deodorant Tampons
FDA 510(k) K810143 · Tampax, Inc.
510(k) numberK810143
Submission
- Device name
- Tampax Deodorant Tampons
- Applicant
- Tampax, Inc.
Walker, MI, US - Received
- January 21, 1981
- Decision date
- March 4, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K832973 | Tampax Super Deodorant MaxithinsHHL · Traditional | 11/28/1983SE |
| K832972 | Regular Deodorant Maxithins PadsHHL · Traditional | 11/28/1983SE |
| K832971 | Deodorant Maxithins Panty ShieldHHL · Traditional | 11/28/1983SE |
| K832974 | Maxithins Unscented Panty ShieldsHHD · Traditional | 10/14/1983SE |
| K821800 | Regular Maxithins Pads & Super MaxithinsHHD · Traditional | 06/25/1982SE |
| K820174 | Tampax TamponsHEB · Traditional | 03/18/1982SE |
| K813642 | Petal Soft Plastic Applicator TampaxHEB · Traditional | 01/25/1982SE |
| K810160 | Tampax Maxithins PadsHHD · Traditional | 01/28/1981SE |
| K802760 | Petal Soft Plastic Applicator TampaxHEB · Traditional | 01/12/1981SE |
| K800777 | Tampax TamponsHEB · Traditional | 05/14/1980SE |
Questions and answers
When was Tampax Deodorant Tampons cleared by the FDA?
Tampax Deodorant Tampons (K810143) received a 510(k) decision of Substantially Equivalent on March 4, 1981, 42 days after the submission was received.
What is the product code of K810143?
The FDA product code is HIL – Tampon, Menstrual, Scented, Scented-Deodorized, a Class II (moderate risk) device regulated under 21 CFR 884.5460.