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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
Device Name FEMMYCYCLE
Applicant
Femcap Incorporated
27001 La Paz Rd.
Suite 312
Mission Viejo,  CA  92691
Applicant Contact ALBERT REGO
Correspondent
Femcap Incorporated
27001 La Paz Rd.
Suite 312
Mission Viejo,  CA  92691
Correspondent Contact ALBERT REGO
Regulation Number884.5400
Classification Product Code
HHE  
Date Received06/26/2012
Decision Date 11/15/2012
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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