Tosama 100% Organic Cotton Menstrual Tampon

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 Tosama 100% Organic Cotton Menstrual Tampon.

Pre-market Notification Details

Device IDK151170
510k NumberK151170
Device Name:Tosama 100% Organic Cotton Menstrual Tampon
ClassificationTampon, Menstrual, Unscented
Applicant TOSAMA D.O.O. SARANOVICEVA CESTA 35 VIR Vir, Domzale,  SI 1230
ContactMarjetka Kralj Kuncic
CorrespondentDave Yungvirt
THIRD PARTY REVIEW GROUP, LLC 45 ROCKEFELLER PLAZA SUITE 2000 New York,  NY  10111
Product CodeHEB  
CFR Regulation Number884.5470 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2015-05-01
Decision Date2015-07-02
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00860178002653 K151170 000
00860178002646 K151170 000
00860178002639 K151170 000
00860178002622 K151170 000
00860178002615 K151170 000
00860178002608 K151170 000

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