LIL-LETS SILK COMFORT COMPACT, PLASTIC APPLICATOR, LITE, REGULAR, SUPER, SUPER PLUS AND ULTRA LIL-LETS NON APPLICATOR,

Tampon, Menstrual, Unscented

TOSAMA D.O.O.

The following data is part of a premarket notification filed by Tosama D.o.o. with the FDA for Lil-lets Silk Comfort Compact, Plastic Applicator, Lite, Regular, Super, Super Plus And Ultra Lil-lets Non Applicator,.

Pre-market Notification Details

Device IDK120481
510k NumberK120481
Device Name:LIL-LETS SILK COMFORT COMPACT, PLASTIC APPLICATOR, LITE, REGULAR, SUPER, SUPER PLUS AND ULTRA LIL-LETS NON APPLICATOR,
ClassificationTampon, Menstrual, Unscented
Applicant TOSAMA D.O.O. SARANOVICEVA CESTA 035 Vir, Domzale,  SI 1230
ContactMarjetka Kralj Kuncic
CorrespondentMarjetka Kralj Kuncic
TOSAMA D.O.O. SARANOVICEVA CESTA 035 Vir, Domzale,  SI 1230
Product CodeHEB  
CFR Regulation Number884.5470 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-02-16
Decision Date2012-07-13
Summary:summary

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