FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
KOTEX OVERNITE
K Number: K860587
·
Decision Mar 13, 1986
Classifications
1
FEI Numbers
307
Registration Numbers
307
Same Product Code
135
Applicant Total
104
Review Days
22
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Basic Information
- Device Name
- KOTEX OVERNITE
- K Number
- K860587
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 884.5435
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Applicant
- Kimberly-Clark Corp.
- Date Received
- February 19, 1986
- Decision Date
- March 13, 1986
- 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
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FLUSHIES FLUSHABLE/BIODEGRADABLE MENSTRUAL PADS/NAPKINS (ULTRA THINS)
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Other Clearances by Kimberly-Clark Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K140963 | KIMGUARD SMART-FOLD STERILIZATION WRAP | Nov 10, 2014 | Substantially Equivalent |
| K141294 | U BY KOTEX SECURITY UNSCENTED MENSTRUAL TAMPONS | Aug 25, 2014 | Substantially Equivalent |
| K131879 | KC 300 SURGICAL MASK | Dec 20, 2013 | Substantially Equivalent |
| K131841 | KIMBERLY-CLARK LAVENDER NITRILE POWDER-FREE EXAM GLOVE | Nov 7, 2013 | Substantially Equivalent |
| K131254 | KIMVENT MICROCUFF SUBGLOTTIC SUCTIONING ENDOTRACHEAL TUBE | Aug 20, 2013 | Substantially Equivalent |
| K120985 | KIMVENT MICROCUFF SUBGLOTTIC SUCTIONING | Dec 19, 2012 | Substantially Equivalent |
| K112805 | KIMGUARD ONE-STEP STERILIZATION WRAP | Jun 22, 2012 | Substantially Equivalent |
| K113423 | KIMBERLY CLARK PURPLE NITRILE, AND PURPLE NITRILE XTRA POWDER FREE EXAM GLOVE | Mar 9, 2012 | Substantially Equivalent |
| K112300 | KIMGUARD SMART-FOLD* STERILIZATION WRAP | Jan 19, 2012 | Substantially Equivalent |
| K112635 | U BY KOTEX SLEEK UNSCENTED MENSTRUAL TAMPONS | Oct 7, 2011 | Substantially Equivalent |