FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SATIN TOUCH DEODORANT TAMPON JUNIOR, REGULAR, SUPER, SUPER PLUS
K Number: K952344
·
Decision Jul 28, 1995
Classifications
1
FEI Numbers
26
Registration Numbers
27
Same Product Code
83
Applicant Total
70
Review Days
70
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Basic Information
- Device Name
- SATIN TOUCH DEODORANT TAMPON JUNIOR, REGULAR, SUPER, SUPER PLUS
- K Number
- K952344
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.5460
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Tambrands, Inc.
- Date Received
- May 19, 1995
- Decision Date
- July 28, 1995
- Product Code
- HIL
- 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 |
|---|---|---|---|
| HIL | Tampon, Menstrual, Scented, Scented-Deodorized | FDA class 2 | Obstetrics/Gynecology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HIL), ordered by most recent decision date.
ONTEX AND OTHERS PROPRIETARY NAMES
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
PLAYTEX (SCENTED AND UNSCENTED) SPORT FRESH BALANCE TAMPONS
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
PLAYTEX GENTLE GLIDE SCENTED TAMPONS AND PLAYTEX GENTLE GLIDE UNSCENTED TAMPONS
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
PLAYTEX SPORT (UNSCENTED) ,(SCENTED) WITH ODORSHIELD
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
TAMPAX PEARL PLASTIC APPLICATOR TAMPONS, SCENTED AND UNSCENTED
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
PLAYTEX GENTILE GLIDE, PLAYTEX GENTILE GLIDE MULTIPACK 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 |
| K960341 | TAMPAX TAMPON WITH ADDITIVE JUNIOR,REGULAR,SUPER, AND SUPER PLUS | Apr 17, 1996 | 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 |