FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PADS, MINI, MAXI
K Number: K782112
·
Decision Jan 8, 1979
Classifications
1
FEI Numbers
310
Registration Numbers
310
Same Product Code
135
Applicant Total
10
Review Days
21
Basic Information
- Device Name
- PADS, MINI, MAXI
- K Number
- K782112
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 884.5435
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Applicant
- INTL. PLAYTEX, INC.
- Date Received
- December 18, 1978
- Decision Date
- January 8, 1979
- Product Code
- HHD
- 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 |
|---|---|---|---|
| HHD | Pad, Menstrual, Unscented | FDA class 1 | Obstetrics/Gynecology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HHD), ordered by most recent decision date.
ALWAYS MENSTRUAL PADS
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ALWAYS DUETS
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ENVIVE MINIFORMS
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UNSCENTED INTERLABIAL MENSTRUAL PAD
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GLADRAGS COTTON MENSTRUAL PAD
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FLUSHIES FLUSHABLE/BIODEGRADABLE MENSTRUAL PADS/NAPKINS (ULTRA THINS)
FDA 510(k)
FDA Class 1
·Obstetrics/Gynecology
Other Clearances by INTL. PLAYTEX, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K871197 | PLAYTEX TAMPONS AND DEODORANT TAMPONS | May 12, 1987 | Substantially Equivalent |
| K861738 | PLAYTEX TAMPONS | Jul 22, 1986 | Substantially Equivalent |
| K854258 | PLAYTEX LIGHT'N GENTLE UNSCENTED/DEODORANT/MINI TA | Nov 21, 1985 | Substantially Equivalent |
| K852063 | PLAYTEX SLENDER REG. TAMPONS & DEODORANT TAMPONS | May 22, 1985 | Substantially Equivalent |
| K851356 | PLAYTEX SUPER TAMPONS & SUPER DEODORANT TAMPONS | Apr 12, 1985 | Substantially Equivalent |
| K851355 | PLAYTEX SUPER PLUS TAMPONS & DEODORANT TAMPONS | Apr 12, 1985 | Substantially Equivalent |
| K782111 | PADS, MINI, MAXI DEODORANT | Jan 8, 1979 | Substantially Equivalent |
| K760425 | TAMPON, PLAYTEX 2 VERSION A | Sep 13, 1976 | Substantially Equivalent |
| K760426 | TAMPON, PLAYTEX 2 VERSION B | Aug 26, 1976 | Substantially Equivalent |