Modified Untreated Tampax Tampons
FDA 510(k) K780648 · Tampax, Inc.
510(k) numberK780648
Submission
- Device name
- Modified Untreated Tampax Tampons
- Applicant
- Tampax, Inc.
Walker, MI, US - Received
- April 17, 1978
- Decision date
- May 31, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HEB – Tampon, Menstrual, Unscented
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.5470
- Specialty
- Obstetrics/Gynecology
An unscented 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 HEB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252005 | Livi DeviceHEB · Traditional | Liviwell, Inc. | 03/20/2026SE |
| K253719 | Unscented Menstrual Long Applicator Tampon; Unscented Menstrual Cardboard Applicator…HEB · Special | Unibeauty (Hubei) Technology Co., Ltd. | 12/17/2025SE |
| K252939 | Cohitech Organic Cotton Compact Applicator TamponsHEB · Special | Cotton High Tech S.L. | 10/09/2025SE |
| K252613 | Unscented menstrual three-piece applicator tamponHEB · Special | Unibeauty (Hubei) Technology Co., Ltd. | 09/19/2025SE |
| K251033 | Unscented menstrual long applicator tampon; Unscented menstrual Compact Applicator…HEB · Special | Unibeauty (Hubei) Technology Co., Ltd. | 08/13/2025SE |
| K242105 | SABA TamponsHEB · Traditional | Essity Higiene Y Salud Mexico. S.A. DE C.V. | 04/01/2025SE |
| K241064 | Unscented TamponHEB · Traditional | Shandong Intco Hygiene Products Co., Ltd. | 01/10/2025SE |
| K240708 | Organic Cotton Tampon; Organic Cotton PESCVcord TamponHEB · Traditional | Suzhou Borage Medical Technology Co., Ltd. | 05/10/2024SE |
| K232060 | TOSAMA Reusable ApplicatorHEB · Traditional | Tosama, D.O.O. | 04/12/2024SE |
| K232598 | Unscented Menstrual TamponHEB · Traditional | Unibeauty (Hubei) Technology Co., Ltd. | 12/15/2023SE |
More from Unibeauty (Hubei) Technology Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K832973 | Tampax Super Deodorant MaxithinsHHL · Traditional | 11/28/1983SE |
| K832972 | Regular Deodorant Maxithins PadsHHL · Traditional | 11/28/1983SE |
| K832971 | Deodorant Maxithins Panty ShieldHHL · 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 |
Questions and answers
When was Modified Untreated Tampax Tampons cleared by the FDA?
Modified Untreated Tampax Tampons (K780648) received a 510(k) decision of Substantially Equivalent on May 31, 1978, 44 days after the submission was received.
What is the product code of K780648?
The FDA product code is HEB – Tampon, Menstrual, Unscented, a Class II (moderate risk) device regulated under 21 CFR 884.5470.