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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Condom
510(k) Number K031007
Device Name KWIKEZE MALE CONDOM APPLICATOR
Applicant
Condax, LLC
1219 Little Creek Rd.
P.O. Box 12139
Durham,  NC  27709
Applicant Contact ELI J CARTER
Correspondent
Condax, LLC
1219 Little Creek Rd.
P.O. Box 12139
Durham,  NC  27709
Correspondent Contact ELI J CARTER
Regulation Number884.5300
Classification Product Code
HIS  
Subsequent Product Code
LTZ  
Date Received03/31/2003
Decision Date 11/14/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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