FOCUS TOUCH CONCEPTION SYSTEM


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

Correspodent Contact niki c spaniel
Regulation Number 884.5250
Classification Product Code
OBB  
Date Received 08/01/2011
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 NCT01564940NCT01585012
Reviewed by Third Party No

Combination Product

No