FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TAMPAX DEODORANT TAMPONS
K Number: K810143
·
Decision Mar 4, 1981
Classifications
1
FEI Numbers
26
Registration Numbers
27
Same Product Code
83
Applicant Total
12
Review Days
42
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Basic Information
- Device Name
- TAMPAX DEODORANT TAMPONS
- K Number
- K810143
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.5460
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Applicant
- Tampax, Inc.
- Date Received
- January 21, 1981
- Decision Date
- March 4, 1981
- 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 Tampax, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K832972 | REGULAR DEODORANT MAXITHINS PADS | Nov 28, 1983 | Substantially Equivalent |
| K832973 | TAMPAX SUPER DEODORANT MAXITHINS | Nov 28, 1983 | Substantially Equivalent |
| K832971 | DEODORANT MAXITHINS PANTY SHIELD | Nov 28, 1983 | Substantially Equivalent |
| K832974 | MAXITHINS UNSCENTED PANTY SHIELDS | Oct 14, 1983 | Substantially Equivalent |
| K821800 | REGULAR MAXITHINS PADS & SUPER MAXITHINS | Jun 25, 1982 | Substantially Equivalent |
| K820174 | TAMPAX TAMPONS | Mar 18, 1982 | Substantially Equivalent |
| K813642 | PETAL SOFT PLASTIC APPLICATOR TAMPAX | Jan 25, 1982 | Substantially Equivalent |
| K810160 | TAMPAX MAXITHINS PADS | Jan 28, 1981 | Substantially Equivalent |
| K802760 | PETAL SOFT PLASTIC APPLICATOR TAMPAX | Jan 12, 1981 | Substantially Equivalent |
| K800777 | TAMPAX TAMPONS | May 14, 1980 | Substantially Equivalent |