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: 09/09/2011
Date Received: 10/07/2011
Decision Date: 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: 09/09/2011
Date Received: 10/07/2011
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Obstetrics/Gynecology
- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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