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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 K150897
Device Name Tosama 100% Cotton Menstrual Tampon
Applicant
TOSAMA D.O.O.
SARANOVICEVA CESTA 035
VIR, DOMZALE,  SI 1230
Applicant Contact Marjetka Kralj Kuncic
Correspondent
THIRD PARTY REVIEW GROUP, LLC
45 ROCKEFELLER PLAZA
SUITE 2000
NEW YORK,  NY  10111
Correspondent Contact DAVE YUNGVIRT
Regulation Number884.5470
Classification Product Code
HEB  
Date Received04/02/2015
Decision Date 04/20/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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