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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cup, Menstrual
510(k) Number K070965
Device Name ALICIA MENSTRUAL CUP
Applicant
Alicia International Pty , Ltd.
P.O. Box 1471
Oxenford, Queensland,  AU 4210
Applicant Contact TOM STONE
Correspondent
Alicia International Pty , Ltd.
P.O. Box 1471
Oxenford, Queensland,  AU 4210
Correspondent Contact TOM STONE
Regulation Number884.5400
Classification Product Code
HHE  
Date Received04/05/2007
Decision Date 03/05/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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