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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 K072747
Device Name UNIDUS MAGNUM MALE LATEX CONDOM
Applicant
UNIDUS CORP.
507 SHALLOW CREEK ROAD
TUSCALOOSA,  AL  35406
Applicant Contact CLAUDE L WRIGHT
Correspondent
UNIDUS CORP.
507 SHALLOW CREEK ROAD
TUSCALOOSA,  AL  35406
Correspondent Contact CLAUDE L WRIGHT
Regulation Number884.5300
Classification Product Code
HIS  
Date Received09/27/2007
Decision Date 11/15/2007
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
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