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510(k) Data Aggregation
K Number
K092054Device Name
MOXIE PLASTIC APPLICATOR AND MOXIE NON-APPLICATOR TAMPON
Manufacturer
TOSAMA D.D.
Date Cleared
2009-07-29
(22 days)
Product Code
HEB
Regulation Number
884.5470Why did this record match?
Applicant Name (Manufacturer) :
TOSAMA D.D.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MOXIE 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 tam pon correctly into the vagina (only the MOXIE Plastic Applicator Tampon).
Device Description
The MOXIE tampons are used to absorb menstrual fluid.
The MOXIE series tampons come with a plastic applicator and without a plastic applicator in sizes: Regular, Super ,Super plus and Ultra.
The MOXIE tampons are made of commercial cotton and rayon, a polyethylene/polyester cover, and cotton or rayon string.
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K Number
K080775Device Name
MAXIM PLASTIC APPLICATOR & NON-APPLICATOR TAMPONS
Manufacturer
TOSAMA D.D.
Date Cleared
2008-09-10
(175 days)
Product Code
HEB
Regulation Number
884.5470Why did this record match?
Applicant Name (Manufacturer) :
TOSAMA D.D.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MAXIM 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 MAXIM Plastic Applicator Tampon).
Device Description
The Maxim tampons are used to absorb menstrual fluid.
The Maxim series tampons comes with plastic applicator and without in
sizes: Regular, Super, Super plus, Ultra.
The Maxim tampons are made of commercial cotton and rayon, a
polyethylene/polyester cover, and cotton or rayon string.
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