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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 K033541
Device Name LONG LOVE CONDOM
Applicant
UNIDUS CORP.
1219 LITTLE CREEK RD.
durham,  NC  27713
Applicant Contact eli j carter
Correspondent
UNIDUS CORP.
1219 LITTLE CREEK RD.
durham,  NC  27713
Correspondent Contact eli j carter
Regulation Number884.5300
Classification Product Code
HIS  
Date Received11/10/2003
Decision Date 12/23/2003
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 Yes
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