FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BREATHABLE MINI-SHIELD-PRIVATE LABEL
K Number: K843602
·
Decision Oct 5, 1984
Classifications
1
FEI Numbers
307
Registration Numbers
307
Same Product Code
135
Applicant Total
9
Review Days
23
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Basic Information
- Device Name
- BREATHABLE MINI-SHIELD-PRIVATE LABEL
- K Number
- K843602
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 884.5435
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Applicant
- I.C.D. Industries, Inc.
- Date Received
- September 12, 1984
- Decision Date
- October 5, 1984
- 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 I.C.D. Industries, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K860294 | HOSPITAL TABBED NAPKINS SUPER BELTED FEMININE NAPK | Mar 13, 1986 | Substantially Equivalent |
| K853079 | PROTECTIVE PAD FOR INCONTINENCE | Aug 9, 1985 | Substantially Equivalent |
| K844975 | SCENTED BREATHABLE MINI-SHIELD PRIVATE LABEL BRAND | Feb 25, 1985 | Substantially Equivalent |
| K843886 | SCENTED BREATHABLE PRIVATE LABEL MINI-SH | Oct 25, 1984 | Substantially Equivalent |
| K820288 | MINI SHIELDS MENSTRUAL PADS | Mar 5, 1982 | Substantially Equivalent |
| K820287 | MAXI SHIELDS MENSTRUAL PADS | Mar 5, 1982 | Substantially Equivalent |
| K813251 | UNSCENTED MENSTRUAL PADS-MAXI PADS | Dec 14, 1981 | Substantially Equivalent |
| K813252 | UNSCENTED MENSTRUAL PADS-MINI PADS | Dec 14, 1981 | Substantially Equivalent |