FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
UNSCENTED ULTRATHIN MAXI PAD
K Number: K953668
·
Decision Nov 1, 1995
Classifications
1
FEI Numbers
310
Registration Numbers
310
Same Product Code
135
Applicant Total
14
Review Days
86
Basic Information
- Device Name
- UNSCENTED ULTRATHIN MAXI PAD
- K Number
- K953668
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 884.5435
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- PARAGON TRADE BRANDS, INC.
- Date Received
- August 7, 1995
- Decision Date
- November 1, 1995
- 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 PARAGON TRADE BRANDS, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K983381 | VARIOUS TRADE TAMPONS SOLD UNDER PRIVATE LABELS | Oct 19, 1998 | Substantially Equivalent |
| K981953 | VARIOUS TRADE TAMPONS SOLD UNDER PRIVATE LABELS | Aug 18, 1998 | Substantially Equivalent |
| K962954 | DEODORANT MAXI PAD | Oct 10, 1996 | Substantially Equivalent |
| K962962 | DEODORANT PANTY LINER | Oct 10, 1996 | Substantially Equivalent |
| K962953 | DEODORANT PANTY SHIELD | Oct 10, 1996 | Substantially Equivalent |
| K953333 | MENSTRUAL TAMPON | Dec 6, 1995 | Substantially Equivalent |
| K953667 | UNSCENTED CURVED ULTRATHIN MAXI PADS | Nov 1, 1995 | Substantially Equivalent |
| K953553 | UNSCENTED MENSTRAL PAD | Oct 27, 1995 | Substantially Equivalent |
| K953517 | UNSCENTED MENSTRUAL PAD | Oct 26, 1995 | Substantially Equivalent |
| K953666 | UNSCENTED MENSTRAL PAD WITH WINGS | Sep 27, 1995 | Substantially Equivalent |