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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
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