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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 K040335
Device Name MOONCUP, STYLE A & B
Applicant
MOONCUP LLC
ONE EAST MAIN STREET
MADISON,  WI  53701
Applicant Contact MORRIS WAXLER
Correspondent
MOONCUP LLC
ONE EAST MAIN STREET
MADISON,  WI  53701
Correspondent Contact MORRIS WAXLER
Regulation Number884.5400
Classification Product Code
HHE  
Date Received02/11/2004
Decision Date 03/30/2005
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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