O.B. Applicator Tampons
FDA 510(k) K953638 · Personal Products Co.
510(k) numberK953638
Submission
- Device name
- O.B. Applicator Tampons
- Applicant
- Personal Products Co.
Milltown, NJ, US - Received
- August 4, 1995
- Decision date
- October 20, 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 |
|---|---|---|
| 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 |
| K941863 | O.B. TamponHEB · Traditional | 06/27/1994SE |
Questions and answers
When was O.B. Applicator Tampons cleared by the FDA?
O.B. Applicator Tampons (K953638) received a 510(k) decision of Substantially Equivalent on October 20, 1995, 77 days after the submission was received.
What is the product code of K953638?
The FDA product code is HIL – Tampon, Menstrual, Scented, Scented-Deodorized, a Class II (moderate risk) device regulated under 21 CFR 884.5460.