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FDA 510(k), K103311, U BY KOTEX CLICK UNSCENTED MENSTRUL TAMPONS
FDA 510(k), K103311, U BY KOTEX CLICK UNSCENTED MENSTRUL TAMPONS
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510(K) Number: K103311
Device Name: U BY KOTEX CLICK UNSCENTED MENSTRUL TAMPONS
Manufacturer: CHERYL SANZARE
Device Classification Name: Tampon, Menstrual, Unscented
Regulation Number: HEB
Classification Product Code: KXA
Date Received: 11/10/2010
Decision Date: 12/10/2010
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Obstetrics/Gynecology
Device Name: U BY KOTEX CLICK UNSCENTED MENSTRUL TAMPONS
Manufacturer: CHERYL SANZARE
Device Classification Name: Tampon, Menstrual, Unscented
Regulation Number: HEB
Classification Product Code: KXA
Date Received: 11/10/2010
Decision Date: 12/10/2010
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Obstetrics/Gynecology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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