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FDA 510(k), K112635, U BY KOTEX SLEEK UNSCENTED MENSTRUAL TAMPONS
FDA 510(k), K112635, U BY KOTEX SLEEK UNSCENTED MENSTRUAL TAMPONS
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510(K) Number: K112635
Device Name: U BY KOTEX SLEEK UNSCENTED MENSTRUAL TAMPONS
Manufacturer: Swarna Mukund
Device Classification Name: Tampon, Menstrual, Unscented
Regulation Number: HEB
Classification Product Code: KXA
Date Received: 09/09/2011
Decision Date: 10/07/2011
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Obstetrics/Gynecology
Device Name: U BY KOTEX SLEEK UNSCENTED MENSTRUAL TAMPONS
Manufacturer: Swarna Mukund
Device Classification Name: Tampon, Menstrual, Unscented
Regulation Number: HEB
Classification Product Code: KXA
Date Received: 09/09/2011
Decision Date: 10/07/2011
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Obstetrics/Gynecology
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