FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
U BY KOTEX SLEEK UNSCENTED MENSTRUAL TAMPONS
K Number: K112635
·
Decision Oct 7, 2011
Classifications
1
FEI Numbers
92
Registration Numbers
93
Same Product Code
188
Applicant Total
104
Review Days
28
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Basic Information
- Device Name
- U BY KOTEX SLEEK UNSCENTED MENSTRUAL TAMPONS
- K Number
- K112635
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 884.5470
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Kimberly-Clark Corp.
- Date Received
- September 9, 2011
- Decision Date
- October 7, 2011
- 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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| 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 |
| K110455 | KIMBERLY-CLARK LOW BARRIER, ASTM 2100 FACE MASKS | Apr 29, 2011 | Substantially Equivalent |