Deodorant Maxithins Panty Shield
FDA 510(k) K832971 · Tampax, Inc.
510(k) numberK832971
Submission
- Device name
- Deodorant Maxithins Panty Shield
- Applicant
- Tampax, Inc.
Mchenry, IL, US - Received
- September 1, 1983
- Decision date
- November 28, 1983
- 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 |
| K884951 | Tampax Ultrafit Panty Shields, DeodorantHHL · Traditional | Tambrands, Inc. | 01/10/1989SE |
| K884446 | Maxithins Super Pads, DeodorantHHL · Traditional | Tambrands, Inc. | 12/20/1988SE |
More from Tambrands, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K832973 | Tampax Super Deodorant MaxithinsHHL · Traditional | 11/28/1983SE |
| K832972 | Regular Deodorant Maxithins PadsHHL · 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 |
| K810143 | Tampax Deodorant TamponsHIL · Traditional | 03/04/1981SE |
| 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 Deodorant Maxithins Panty Shield cleared by the FDA?
Deodorant Maxithins Panty Shield (K832971) received a 510(k) decision of Substantially Equivalent on November 28, 1983, 88 days after the submission was received.
What is the product code of K832971?
The FDA product code is HHL – Pad, Menstrual, Scented, Scented-Deodorized, a Class II (moderate risk) device regulated under 21 CFR 884.5425.