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
  • Status: Pending Fast-Track Request
  • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

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