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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 K912405
Device Name LATEX PROPHYLACTIC (CONDOM)
Applicant
HEVEALACTICS INTL. SDN BHD
C/O SAMSUNG AMERICA, STE 201
14251 E FIRESTONE BLVD
LA MIRADA,  CA  90638
Applicant Contact YONG W KOO
Correspondent
HEVEALACTICS INTL. SDN BHD
C/O SAMSUNG AMERICA, STE 201
14251 E FIRESTONE BLVD
LA MIRADA,  CA  90638
Correspondent Contact YONG W KOO
Regulation Number884.5300
Classification Product Code
HIS  
Date Received05/30/1991
Decision Date 07/21/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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