FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
KOTEX STICK TAMPONS, REGULAR AND SUPER
K Number: K884305
·
Decision Dec 20, 1988
Classifications
1
FEI Numbers
92
Registration Numbers
93
Same Product Code
188
Applicant Total
104
Review Days
68
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Basic Information
- Device Name
- KOTEX STICK TAMPONS, REGULAR AND SUPER
- K Number
- K884305
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.5470
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Applicant
- Kimberly-Clark Corp.
- Date Received
- October 13, 1988
- Decision Date
- December 20, 1988
- Product Code
- HEB
- 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 |
|---|---|---|---|
| HEB | Tampon, Menstrual, Unscented | FDA class 2 | Obstetrics/Gynecology |
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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 |