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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 K063227
Device Name CONCEIVEX CONCEPTION KIT
Applicant
CONCEIVEX INC.
2600 MULLINIX MILL ROAD
MT. AIRY,  MD  21771
Applicant Contact BLIX WINSTON
Correspondent
CONCEIVEX INC.
2600 MULLINIX MILL ROAD
MT. AIRY,  MD  21771
Correspondent Contact BLIX WINSTON
Regulation Number884.5250
Classification Product Code
OBB  
Date Received10/24/2006
Decision Date 03/14/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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