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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 K232060
Device Name TOSAMA Reusable Applicator
Applicant
Tosama, D.O.O.
Vir, Saranoviceva Cesta 35
Domžale,  SI 1230
Applicant Contact Janez Obreza
Correspondent
Tosama, D.O.O.
Vir, Saranoviceva Cesta 35
Domžale,  SI 1230
Correspondent Contact Janez Obreza
Regulation Number884.5470
Classification Product Code
HEB  
Subsequent Product Code
HIL  
Date Received07/11/2023
Decision Date 04/12/2024
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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