FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TAMPON, PETAL SOFT PLASTIC APPLICATOR, SUPER PLUS
K Number: K896113
·
Decision Dec 13, 1989
Classifications
1
FEI Numbers
93
Registration Numbers
94
Same Product Code
183
Applicant Total
70
Review Days
51
Basic Information
- Device Name
- TAMPON, PETAL SOFT PLASTIC APPLICATOR, SUPER PLUS
- K Number
- K896113
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.5470
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Applicant
- TAMBRANDS, INC.
- Date Received
- October 23, 1989
- Decision Date
- December 13, 1989
- 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 |
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Other Clearances by TAMBRANDS, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K962476 | UNSCENTED MENSTRUAL TAMPON, PLASTIC APPLICATOR | Aug 13, 1996 | Substantially Equivalent |
| K960341 | TAMPAX TAMPON WITH ADDITIVE JUNIOR,REGULAR,SUPER, AND SUPER PLUS | Apr 17, 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 |
| K924303 | TAMPAX TAMPON, REGULAR ABSORBENCY | Jul 29, 1993 | Substantially Equivalent |
| K923932 | TAMPAX TAMPONS, SUPER ABSORBENCY | Jul 29, 1993 | Substantially Equivalent |
| K896989 | TAMPAX TAMPON | Dec 22, 1989 | Substantially Equivalent |
| K896114 | TAMPON, PETAL SOFT PLASTIC APPLI., SUPER ABSORB. | Dec 13, 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 |