510(k) K112200

Device: FOCUS TOUCH CONCEPTION SYSTEM
Applicant: INTIMATE BRIDGE 2 CONCEPTION, INC
510(k) number: K112200
Product code: OBB
Decision: Substantially Equivalent (SESE)
Decision date: 2012-09-06
Date received: 2011-08-01
Regulation: 884.5250
Classification name: Kit, Conception-assist, Home Use
Medical specialty: Obstetrics/Gynecology
Review panel: Obstetrics/Gynecology
Device class: 2
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: No

Applicant Contact#

Contact: NIKI C SPANIEL
Address: 3919 William Penn Hwy. Suite 200 Murrysville PA US 15668 15668

FDA Registration Numbers#

3038597712
3013756293

Source Documents#

Other 510(k) Records For Product Code OBB #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K140186	THE STORK OTC	Rinovum Women'S Health, Inc.	2014-07-11
K080752	CONCEIVEX LATEX-FREE SEMEN COLLECTOR	Conceivex, Inc.	2008-05-14
K063227	CONCEIVEX CONCEPTION KIT	Conceivex, Inc.	2007-03-14

Legacy Summary#

summary

FDA Review#

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