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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 K120481
Device Name LIL-LETS SILK COMFORT COMPACT, PLASTIC APPLICATOR, LITE, REGULAR, SUPER, SUPER PLUS AND ULTRA LIL-LETS NON APPLICATOR,
Applicant
TOSAMA D.O.O.
SARANOVICEVA CESTA 035
VIR, DOMZALE,  SI 1230
Applicant Contact MARJETKA KRALJ KUNCIC
Correspondent
TOSAMA D.O.O.
SARANOVICEVA CESTA 035
VIR, DOMZALE,  SI 1230
Correspondent Contact MARJETKA KRALJ KUNCIC
Regulation Number884.5470
Classification Product Code
HEB  
Date Received02/16/2012
Decision Date 07/13/2012
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
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