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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 K121857
Model SINGLE DEVICE
Device Name FEMMYCYCLE
Original Applicant
FEMCAP INCORPORATED
27001 la paz road, suite 312
mission viejo,  CA  92691
Original Contact albert rego
Regulation Number884.5400
Classification Product Code
HHE  
Date Received06/26/2012
Decision Date 11/15/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Obstetrics/Gynecology
Review Advisory Committee Obstetrics/Gynecology
statement statement
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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