FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SANITARY/OB NAPKINS
K Number: K822242
·
Decision Sep 9, 1982
Classifications
1
FEI Numbers
307
Registration Numbers
307
Same Product Code
135
Applicant Total
7
Review Days
44
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Basic Information
- Device Name
- SANITARY/OB NAPKINS
- K Number
- K822242
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 884.5435
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Applicant
- Hospital Specialty Co.
- Date Received
- July 27, 1982
- Decision Date
- September 9, 1982
- 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 Hospital Specialty Co.
| K Number | Device Name | ||
|---|---|---|---|
| K990861 | WOUND DRESSING/ABD PAD, MODEL #10810 | Apr 12, 1999 | Substantially Equivalent |
| K941099 | CLEAN-SORB | Sep 30, 1994 | Substantially Equivalent |
| K882094 | GARDS DEODORANT SANITARY NAPKIN | Sep 22, 1988 | Substantially Equivalent |
| K880454 | AT EASE STRESS PAD | Jun 16, 1988 | Substantially Equivalent |
| K880455 | AT EASE ADULT DIAPER | Apr 14, 1988 | Substantially Equivalent |
| K822433 | GARDS (UNSCENTED, MENSTRUAL PAD) | Aug 30, 1982 | Substantially Equivalent |