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510(k) Data Aggregation
K Number
K070965Device Name
ALICIA MENSTRUAL CUP
Manufacturer
ALICIA INTERNATIONAL PTY LTD.
Date Cleared
2008-03-05
(335 days)
Product Code
HHE
Regulation Number
884.5400Why did this record match?
Applicant Name (Manufacturer) :
ALICIA INTERNATIONAL PTY LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Alicia 100 Menstrual Cup / Models 99ALXS, 100ALSM, 101ALMD, 102ALLG is a receptacle placed in the vagina to collect blood and cellular debris that is extruded from the uterus via the cervix during menstruation.
Device Description
The Alicia™ menstrual cup is a soft, small internally worn reusable silicone menstrual cup that holds (instead of absorbing) monthly menstrual flow. It may remain in the body for up to 12 hours. It holds an ounce of fluid. It is available four sizes:
· L size: 102ALLG; for larger built women that have had children.
· M size: 101ALMD; for women who have had vaginal childbirth or C-Section; and for women who are over 30 years old and never had childbirth.
S size: 100ALSM; for women under 30 years old who have never had childbirth or C-Section.
· XS size: 99ALXS; for teenagers and very small framed women.
The cup remains entirely within the vagina and does not tough the cervix but the stem remains outside the body to ensure retrieval of the cup.
The Alicia™ menstrual cup is manufactured from a soft silicone elastomer.
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