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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name kit, conception-assist, home use
510(k) Number K112200
Model 001
Device Name FOCUS TOUCH CONCEPTION SYSTEM
Original Applicant
INTIMATE BRIDGE 2 CONCEPTION, INC
3919 william penn highway
suite 200
murrysville,  PA  15668
Original Contact niki c spaniel
Regulation Number884.5250
Classification Product Code
OBB  
Date Received08/01/2011
Decision Date 09/06/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Obstetrics/Gynecology
Review Advisory Committee Obstetrics/Gynecology
summary summary
Type Traditional
Clinical Trials NCT01564940
NCT01585012
Reviewed by Third Party No
Expedited Review No
Combination Product No
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