FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MAXITHINS UNSCENTED PANTY SHIELDS
K Number: K832974
·
Decision Oct 14, 1983
Classifications
1
FEI Numbers
307
Registration Numbers
307
Same Product Code
135
Applicant Total
12
Review Days
43
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Basic Information
- Device Name
- MAXITHINS UNSCENTED PANTY SHIELDS
- K Number
- K832974
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 884.5435
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Applicant
- Tampax, Inc.
- Date Received
- September 1, 1983
- Decision Date
- October 14, 1983
- 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
FDA 510(k)
FDA Class 1
·Obstetrics/Gynecology
ALWAYS DUETS
FDA 510(k)
FDA Class 1
·Obstetrics/Gynecology
ENVIVE MINIFORMS
FDA 510(k)
FDA Class 1
·Obstetrics/Gynecology
UNSCENTED INTERLABIAL MENSTRUAL PAD
FDA 510(k)
FDA Class 1
·Obstetrics/Gynecology
GLADRAGS COTTON MENSTRUAL PAD
FDA 510(k)
FDA Class 1
·Obstetrics/Gynecology
FLUSHIES FLUSHABLE/BIODEGRADABLE MENSTRUAL PADS/NAPKINS (ULTRA THINS)
FDA 510(k)
FDA Class 1
·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 |
| 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 |
| K800777 | TAMPAX TAMPONS | May 14, 1980 | Substantially Equivalent |