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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 K060852
Device Name MOONCUP
Applicant
Mooncup Limited
Dolphin House
40 Arundel St.
Brighton,  GB BN2 1GD
Applicant Contact SU HARDY
Correspondent
Mooncup Limited
Dolphin House
40 Arundel St.
Brighton,  GB BN2 1GD
Correspondent Contact SU HARDY
Regulation Number884.5400
Classification Product Code
HHE  
Date Received03/28/2006
Decision Date 12/26/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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