U BY KOTEX CLICK UNSCENTED MENSTRUL TAMPONS
FDA 510(k) clearance K103311 · decided 2010-12-10
Clearance details
- K-number
- K103311
- Device name
- U BY KOTEX CLICK UNSCENTED MENSTRUL TAMPONS
- Applicant
- Kimberly Clark Corporation
- Decision
- Substantially Equivalent
- Date received
- 2010-11-10
- Decision date
- 2010-12-10
- Days to decision
- 30 days
- Clearance type
- Special
- Product code
- HEB
- Device class
- 2
- Regulation number
- 884.5470
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Neenah, WI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.