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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 K080752
Device Name CONCEIVEX LATEX-FREE SEMEN COLLECTOR
Applicant
Conceivex, Inc.
2600 Mullinix Mill Rd.
Mt. Airy,  MD  21771
Applicant Contact BLIX WINSTON
Correspondent
Conceivex, Inc.
2600 Mullinix Mill Rd.
Mt. Airy,  MD  21771
Correspondent Contact BLIX WINSTON
Regulation Number884.5250
Classification Product Code
OBB  
Date Received03/17/2008
Decision Date 05/14/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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