Tampax Pearl Scented Tampons-Junior, Regular, Super & Super Plus
FDA 510(k) K040312 · Procter & Gamble Co.
510(k) numberK040312
Submission
- Device name
- Tampax Pearl Scented Tampons-Junior, Regular, Super & Super Plus
- Applicant
- Procter & Gamble Co.
Cincinnati, OH, US - Received
- February 9, 2004
- Decision date
- May 3, 2004
- 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.
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| 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 |
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| K203567 | Oral-B Dry Mouth Oral RinseLFD · Traditional | 04/05/2021SE |
| K201277 | Oral-B Dry Mouth Oral RinseLFD · Traditional | 09/02/2020SE |
| K200881 | Oral-B iO Test Drive Power Brush Trial Program KitJEQ · Traditional | 08/27/2020SE |
| K151413 | Always/Tampax bladder supportsHHW · Traditional | 12/18/2015SE |
| K141018 | Oral-B Test Drive Power Brush Trial Program Kit, Oral-B Test Drive Power Toothbrush Kit…JEQ · Traditional | 09/15/2014SE |
| K133244 | Tampax M Plastic Tampons, UnscentedHEB · Special | 01/09/2014SE |
| K131543 | Tampax(R) L Plastic Tampons, UnscentedHEB · Special | 06/20/2013SE |
| K113699 | Tampax(R) V Plastic Applicator Tampons, UnscentedHEB · Special | 01/12/2012SE |
| K110669 | Tampax C Plastic Tampons, UnscentedHEB · Special | 06/02/2011SE |
| K091281 | Tampax Pearl Unscented Tampons, Light, Regular, Super & Super Plus, Tampax Pearl…HEB · Traditional | 06/01/2010SE |
Questions and answers
When was Tampax Pearl Scented Tampons-Junior, Regular, Super & Super Plus cleared by the FDA?
Tampax Pearl Scented Tampons-Junior, Regular, Super & Super Plus (K040312) received a 510(k) decision of Substantially Equivalent on May 3, 2004, 84 days after the submission was received.
What is the product code of K040312?
The FDA product code is HIL – Tampon, Menstrual, Scented, Scented-Deodorized, a Class II (moderate risk) device regulated under 21 CFR 884.5460.