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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 K140186
Device Name THE STORK OTC
Applicant
RINOVUM WOMEN'S HEALTH, INC
300 Oxford Dr Suite 330
Monroeville,  PA  15146
Applicant Contact ANDREW ZELTWANGER
Correspondent
RINOVUM WOMEN'S HEALTH, INC
300 Oxford Dr Suite 330
Monroeville,  PA  15146
Correspondent Contact ANDREW ZELTWANGER
Regulation Number884.5250
Classification Product Code
OBB  
Date Received01/24/2014
Decision Date 07/11/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Clinical Trials NCT02038322
Reviewed by Third Party No
Combination Product No
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