510(k) K080752

Device: CONCEIVEX LATEX-FREE SEMEN COLLECTOR
Applicant: CONCEIVEX INC.
510(k) number: K080752
Product code: OBB
Decision: Substantially Equivalent (SESE)
Decision date: 2008-05-14
Date received: 2008-03-17
Regulation: 884.5250
Classification name: Kit, Conception-assist, Home Use
Medical specialty: Obstetrics/Gynecology
Review panel: Obstetrics/Gynecology
Device class: 2
Clearance type: Special
Statement or summary: Summary
Third party reviewed: No

Applicant Contact#

Contact: BLIX WINSTON
Address: 2600 Mullinix Mill Rd. Mt. Airy MD US 21771 21771

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
K112200	FOCUS TOUCH CONCEPTION SYSTEM	Intimate Bridge 2 Conception, Inc.	2012-09-06
K063227	CONCEIVEX CONCEPTION KIT	Conceivex, Inc.	2007-03-14

Legacy Summary#

summary

FDA Review#

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