FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SURE & NATURAL MAXISHIELDS W/SUPERABSORBENT
K Number: K844342
·
Decision Jan 10, 1985
Classifications
1
FEI Numbers
307
Registration Numbers
307
Same Product Code
135
Applicant Total
45
Review Days
63
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Basic Information
- Device Name
- SURE & NATURAL MAXISHIELDS W/SUPERABSORBENT
- K Number
- K844342
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 884.5435
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Applicant
- Personal Products Co.
- Date Received
- November 8, 1984
- Decision Date
- January 10, 1985
- 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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FDA Class 1
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GLADRAGS COTTON MENSTRUAL PAD
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FDA Class 1
·Obstetrics/Gynecology
FLUSHIES FLUSHABLE/BIODEGRADABLE MENSTRUAL PADS/NAPKINS (ULTRA THINS)
FDA 510(k)
FDA Class 1
·Obstetrics/Gynecology
Other Clearances by Personal Products Co.
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|---|---|---|---|
| K070545 | K-Y BRAND WARMING LIQUID | Mar 23, 2007 | Substantially Equivalent |
| K062796 | K-Y BRAND INTRIGUE | Dec 8, 2006 | Substantially Equivalent |
| K010365 | ORTHO CONTROL FEMALE URINARY CONTROL DEVICE | Apr 30, 2001 | Substantially Equivalent |
| K990536 | O.B. TAMPON | Aug 31, 1999 | Substantially Equivalent |
| K991118 | O.B. APPLICATOR TAMPONS, O.B. TAMPONS | Jun 29, 1999 | Substantially Equivalent |
| K974629 | O.B. APPLICATOR AND NON-APPLICATOR TAMPONS | Feb 10, 1998 | Substantially Equivalent |
| K971589 | REACH ANTIBACTERIAL TOOTHBRUSH | Jul 24, 1997 | Substantially Equivalent |
| K970954 | O.B. APPLICATOR TAMPONS | Jun 10, 1997 | Substantially Equivalent |
| K961119 | CAREFREE PANTYLINERS | Apr 17, 1996 | Substantially Equivalent |
| K953638 | O.B. APPLICATOR TAMPONS | Oct 20, 1995 | Substantially Equivalent |