FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TAMPAX TAMPONS
K Number: K800777
·
Decision May 14, 1980
Classifications
1
FEI Numbers
92
Registration Numbers
93
Same Product Code
188
Applicant Total
12
Review Days
36
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Basic Information
- Device Name
- TAMPAX TAMPONS
- K Number
- K800777
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.5470
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Applicant
- Tampax, Inc.
- Date Received
- April 8, 1980
- Decision Date
- May 14, 1980
- 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.
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Unscented Menstrual Long Applicator Tampon; Unscented Menstrual Cardboard Applicator Tampon; Unscented Menstrual Digital Tampons
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COHITECH ORGANIC COTTON COMPACT APPLICATOR TAMPONS
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Unscented menstrual three-piece applicator tampon
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Unscented menstrual long applicator tampon; Unscented menstrual Compact Applicator Tampon; Unscented menstrual Cardboard Applicator Tampon; Unscented menstrual Digital Tampons
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SABA Tampons
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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 |
| K810143 | TAMPAX DEODORANT TAMPONS | Mar 4, 1981 | Substantially Equivalent |
| K810160 | TAMPAX MAXITHINS PADS | Jan 28, 1981 | Substantially Equivalent |
| K802760 | PETAL SOFT PLASTIC APPLICATOR TAMPAX | Jan 12, 1981 | Substantially Equivalent |