MOXIE PLASTIC APPLICATOR AND MOXIE NON-APPLICATOR TAMPON

Tampon, Menstrual, Unscented

TOSAMA D.D.

The following data is part of a premarket notification filed by Tosama D.d. with the FDA for Moxie Plastic Applicator And Moxie Non-applicator Tampon.

Pre-market Notification Details

Device IDK092054
510k NumberK092054
Device Name:MOXIE PLASTIC APPLICATOR AND MOXIE NON-APPLICATOR TAMPON
ClassificationTampon, Menstrual, Unscented
Applicant TOSAMA D.D. SARANOVICEVA CESTA 035 Vir, Domzale,  SI 1230
ContactAntonija Vidensek
CorrespondentAntonija Vidensek
TOSAMA D.D. SARANOVICEVA CESTA 035 Vir, Domzale,  SI 1230
Product CodeHEB  
CFR Regulation Number884.5470 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-07-07
Decision Date2009-07-29
Summary:summary

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