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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 K092985
Device Name BELLECUP
Applicant
LIBRETTE, INC
1705. S. CAPITAL OF TEXAS HWY
SUITE 500
AUSTIN,  TX  78746
Applicant Contact NEAL KOLBER
Correspondent
LIBRETTE, INC
1705. S. CAPITAL OF TEXAS HWY
SUITE 500
AUSTIN,  TX  78746
Correspondent Contact NEAL KOLBER
Regulation Number884.5400
Classification Product Code
HHE  
Date Received09/28/2009
Decision Date 06/28/2010
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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