Panty-Liners Scented
FDA 510(k) K830144 · Procter & Gamble Mfg. Co.
510(k) numberK830144
Submission
- Device name
- Panty-Liners Scented
- Applicant
- Procter & Gamble Mfg. Co.
Mchenry, IL, US - Received
- January 17, 1983
- Decision date
- January 21, 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 |
|---|---|---|
| K873457 | Scented or Scented Deodorized Menstrual PadsHIL · Traditional | 01/19/1988SE |
| K873036 | Attends Incontinent BriefEYQ · Traditional | 01/19/1988SE |
| K864673 | Unscented Menstrual PadHHL · Traditional | 01/21/1987SE |
| K861863 | Modified Protective GarmentEYQ · Traditional | 08/11/1986SE |
| K862348 | Single-Use Patient UnderpadKME · Traditional | 07/02/1986SE |
| K860598 | Modified Protective Garment for IncontinentsEYQ · Traditional | 03/05/1986SE |
| K853880 | Attends Dispos. UnderpadKME · Traditional | 10/16/1985SE |
| K853000 | Scented Always PantilinersHHL · Traditional | 09/06/1985SE |
| K852985 | Unscented Always PantilinersHHD · Traditional | 08/29/1985SE |
| K850956 | Always Maxipads - ScentedHHL · Traditional | 05/14/1985SE |
Questions and answers
When was Panty-Liners Scented cleared by the FDA?
Panty-Liners Scented (K830144) received a 510(k) decision of Substantially Equivalent on January 21, 1983, 4 days after the submission was received.
What is the product code of K830144?
The FDA product code is HHL – Pad, Menstrual, Scented, Scented-Deodorized, a Class II (moderate risk) device regulated under 21 CFR 884.5425.