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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 K092054
Device Name MOXIE PLASTIC APPLICATOR AND MOXIE NON-APPLICATOR TAMPON
Applicant
TOSAMA D.D.
SARANOVICEVA CESTA 035
VIR, DOMZALE,  SI 1230
Applicant Contact ANTONIJA VIDENSEK
Correspondent
TOSAMA D.D.
SARANOVICEVA CESTA 035
VIR, DOMZALE,  SI 1230
Correspondent Contact ANTONIJA VIDENSEK
Regulation Number884.5470
Classification Product Code
HEB  
Date Received07/07/2009
Decision Date 07/29/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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