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510(k) Data Aggregation
K Number
K151170Device Name
Tosama 100% Organic Cotton Menstrual Tampon
Manufacturer
TOSAMA D.O.O.
Date Cleared
2015-07-02
(62 days)
Product Code
HEB
Regulation Number
884.5470Why did this record match?
Applicant Name (Manufacturer) :
TOSAMA D.O.O.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Tosama 100% Organic Cotton Menstrual Tampon is intended for insertion into the vagina for the absorption of menstrual or other vaginal discharge.
Device Description
The device will be offered as a traditional unscented menstrual 100% organic cotton tampon consisting of an absorbent pledget, a withdrawal cord, and an applicator. The pledget is of the traditional cylindrical, bullet-like shape and the applicator has a standard rounded tip to ease insertion. Each tampon is individually wrapped and packaged in multi-unit containers for retail sale. It will be offered in three absorbencies: Regular, Super, and Super Plus.
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K Number
K150897Device Name
Tosama 100% Cotton Menstrual Tampon
Manufacturer
TOSAMA D.O.O.
Date Cleared
2015-04-20
(18 days)
Product Code
HEB
Regulation Number
884.5470Why did this record match?
Applicant Name (Manufacturer) :
TOSAMA D.O.O.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Tosama 100% Cotton Tampon is intended for insertion into the vagina for absorption of menstrual or other vaginal discharge.
Device Description
The device will be offered as a traditional unscented menstrual 100% cotton tampon consisting of an absorbent pledget, a withdrawal cord, and an applicator. The pledget is of the traditional cylindrical, bullet-like shape and the applicator has a standard rounded tip to ease insertion. Each tampon is individually wrapped and packaged in multi-unit containers for retail sale. It will be offered in three absorbencies: Regular, Super, and Super Plus.
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K Number
K120481Device Name
LIL-LETS SILK COMFORT COMPACT, PLASTIC APPLICATOR, LITE, REGULAR, SUPER, SUPER PLUS AND ULTRA LIL-LETS NON APPLICATOR,
Manufacturer
TOSAMA D.O.O.
Date Cleared
2012-07-13
(148 days)
Product Code
HEB
Regulation Number
884.5470Why did this record match?
Applicant Name (Manufacturer) :
TOSAMA D.O.O.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Lil-lets tampons (both types) are unscented tampons for:
• Women's personal hygiene with respect to intra vaginal absorption of menstrual or other vaginal discharge.
• The plastic applicator is for easing the placement of the tampon correctly into the vagina (only the Lil-lets Silk Comfort Compact Plastic Applicator Tampon).
Device Description
Lil-lets tampons are used to absorb menstrual fluid. Lil-lets series tampons come with a plastic applicator and without a plastic applicator in sizes: Lite, Regular, Super, Super plus and Ultra. Lil-lets tampons are made of commercial cotton and rayon, a polyethylene/polyester cover, and cotton or rayon string.
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