Tampax Ultrafit Panty Shields, Deodorant
FDA 510(k) K884951 · Tambrands, Inc.
510(k) numberK884951
Submission
- Device name
- Tampax Ultrafit Panty Shields, Deodorant
- Applicant
- Tambrands, Inc.
Palmer, MA, US - Received
- November 25, 1988
- Decision date
- January 10, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HHL – Pad, Menstrual, Scented, Scented-Deodorized
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.5425
- Specialty
- Obstetrics/Gynecology
Scented or scented-deodorized menstrual pads used to absorb menstrual or other vaginal discharge, including those intended as intralabial pads or reusable menstrual pads. These are made with materials that do not meet the requirements for Class 1 per 21 CFR 884.5425(b).
Other 510(k)s with product code HHL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K962962 | Deodorant Panty LinerHHL · Traditional | Paragon Trade Brands, Inc. | 10/10/1996SE |
| K962954 | Deodorant Maxi PadHHL · Traditional | Paragon Trade Brands, Inc. | 10/10/1996SE |
| K962953 | Deodorant Panty ShieldHHL · Traditional | Paragon Trade Brands, Inc. | 10/10/1996SE |
| K961119 | Carefree PantylinersHHL · Traditional | Personal Products Co. | 04/17/1996SE |
| K913238 | Always, Unscented Menstrual PadHHL · Traditional | Procter & Gamble Co. | 09/23/1991SE |
| K913237 | Always, Scented/Scented Deodorized Menstrual PadHHL · Traditional | Procter & Gamble Co. | 09/23/1991SE |
| K891473 | Tampax Ultrafit Panty Shields/Dedorant-ModificatioHHL · Traditional | Tambrands, Inc. | 06/07/1989SE |
| K890655 | New Freedom Thin Deodorant Maxi PadsHHL · Traditional | Kimberly-Clark Corp. | 05/01/1989SE |
| K884446 | Maxithins Super Pads, DeodorantHHL · Traditional | Tambrands, Inc. | 12/20/1988SE |
| K884445 | Maxithins Panty Shields, DeodorantHHL · Traditional | Tambrands, Inc. | 12/05/1988SE |
More from Tambrands, 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, Deodorant cleared by the FDA?
Tampax Ultrafit Panty Shields, Deodorant (K884951) received a 510(k) decision of Substantially Equivalent on January 10, 1989, 46 days after the submission was received.
What is the product code of K884951?
The FDA product code is HHL – Pad, Menstrual, Scented, Scented-Deodorized, a Class II (moderate risk) device regulated under 21 CFR 884.5425.