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510(k) K140186

Device
THE STORK OTC
Applicant
RINOVUM WOMEN'S HEALTH, INC
510(k) number
K140186
Product code
OBB  
Decision
Substantially Equivalent (SESE)
Decision date
2014-07-11
Date received
2014-01-24
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
ANDREW ZELTWANGER
Address
300 Oxford Dr., Suite 330 Monroeville PA US 15146 15146

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code OBB  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K112200FOCUS TOUCH CONCEPTION SYSTEMIntimate Bridge 2 Conception, Inc.2012-09-06
K080752CONCEIVEX LATEX-FREE SEMEN COLLECTORConceivex, Inc.2008-05-14
K063227CONCEIVEX CONCEPTION KITConceivex, Inc.2007-03-14

Legacy Summary#

summary

FDA Review#

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