FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TAMPAX TAMPON WITH ADDITIVE JUNIOR,REGULAR,SUPER, AND SUPER PLUS
K Number: K960341
·
Decision Apr 17, 1996
Classifications
1
FEI Numbers
92
Registration Numbers
93
Same Product Code
188
Applicant Total
70
Review Days
84
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- TAMPAX TAMPON WITH ADDITIVE JUNIOR,REGULAR,SUPER, AND SUPER PLUS
- K Number
- K960341
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.5470
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Tambrands, Inc.
- Date Received
- January 24, 1996
- Decision Date
- April 17, 1996
- Product Code
- HEB
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| HEB | Tampon, Menstrual, Unscented | FDA class 2 | Obstetrics/Gynecology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HEB), ordered by most recent decision date.
Livi Device
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Unscented Menstrual Long Applicator Tampon; Unscented Menstrual Cardboard Applicator Tampon; Unscented Menstrual Digital Tampons
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
COHITECH ORGANIC COTTON COMPACT APPLICATOR TAMPONS
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Unscented menstrual three-piece applicator tampon
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Unscented menstrual long applicator tampon; Unscented menstrual Compact Applicator Tampon; Unscented menstrual Cardboard Applicator Tampon; Unscented menstrual Digital Tampons
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
SABA Tampons
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Other Clearances by Tambrands, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K962476 | UNSCENTED MENSTRUAL TAMPON, PLASTIC APPLICATOR | Aug 13, 1996 | Substantially Equivalent |
| K952344 | SATIN TOUCH DEODORANT TAMPON JUNIOR, REGULAR, SUPER, SUPER PLUS | Jul 28, 1995 | Substantially Equivalent |
| K944834 | UNSCENTED MENSTRUAL TAMPONS | Dec 21, 1994 | Substantially Equivalent |
| K923932 | TAMPAX TAMPONS, SUPER ABSORBENCY | Jul 29, 1993 | Substantially Equivalent |
| K924303 | TAMPAX TAMPON, REGULAR ABSORBENCY | Jul 29, 1993 | Substantially Equivalent |
| K896989 | TAMPAX TAMPON | Dec 22, 1989 | Substantially Equivalent |
| K896115 | TAMPON, PETAL SOFT PLASTIC APPLI., DEODORANT SUPER | Dec 13, 1989 | Substantially Equivalent |
| K896112 | TAMPAX TAMPON, FLUSHABLE APPLICATOR, SUPER PLUS | Dec 13, 1989 | Substantially Equivalent |
| K896113 | TAMPON, PETAL SOFT PLASTIC APPLICATOR, SUPER PLUS | Dec 13, 1989 | Substantially Equivalent |
| K896114 | TAMPON, PETAL SOFT PLASTIC APPLI., SUPER ABSORB. | Dec 13, 1989 | Substantially Equivalent |