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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
Device Name FOCUS TOUCH CONCEPTION SYSTEM
Applicant
INTIMATE BRIDGE 2 CONCEPTION, INC
3919 WILLIAM PENN HIGHWAY
SUITE 200
MURRYSVILLE,  PA  15668
Applicant Contact NIKI C SPANIEL
Correspondent
INTIMATE BRIDGE 2 CONCEPTION, INC
3919 WILLIAM PENN HIGHWAY
SUITE 200
MURRYSVILLE,  PA  15668
Correspondent Contact NIKI C SPANIEL
Regulation Number884.5250
Classification Product Code
OBB  
Date Received08/01/2011
Decision Date 09/06/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Clinical Trials NCT01564940
NCT01585012
Reviewed by Third Party No
Combination Product No
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