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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 K993781
Device Name SIMPLEX CONDOMS, LATEX CONDOMS-SILICON LUBRICATED
Applicant
P.T. VONIX LATEXINDO CONDOM (RUBBER) MFG.
7 RIVERVIEW RD.
FRAMINGHAM,  MA  01701
Applicant Contact VIJAY MAHAL
Correspondent
P.T. VONIX LATEXINDO CONDOM (RUBBER) MFG.
7 RIVERVIEW RD.
FRAMINGHAM,  MA  01701
Correspondent Contact VIJAY MAHAL
Regulation Number884.5300
Classification Product Code
HIS  
Date Received11/08/1999
Decision Date 02/02/2000
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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