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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tampon, Menstrual, Unscented
510(k) Number K172504
Device Name Tosama Biobased Applicator Tube Menstrual Tampon
Applicant
Tosama, D.O.O.
Saranoviceva Cesta 35
Vir,  SI 1230
Applicant Contact Marjetka Kralj Kuncic
Correspondent
Tosama, D.O.O.
Saranoviceva Cesta 35
Vir,  SI 1230
Correspondent Contact Janez Obreza
Regulation Number884.5470
Classification Product Code
HEB  
Date Received08/18/2017
Decision Date 02/09/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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