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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 K012964
Device Name 56MM CONDOM,MALE NATURAL RUBBER LATEX CONDOM
Applicant
INNOLATEX SDN. BHD
NO. 16, JALAN BULAN U5/5,
BANDAR PINGGIRAN SUBANG
SHAH ALAM, SELANGOR D.E.,  MY 40150
Applicant Contact CHANG AH-KAU
Correspondent
INNOLATEX SDN. BHD
NO. 16, JALAN BULAN U5/5,
BANDAR PINGGIRAN SUBANG
SHAH ALAM, SELANGOR D.E.,  MY 40150
Correspondent Contact CHANG AH-KAU
Regulation Number884.5300
Classification Product Code
HIS  
Date Received09/04/2001
Decision Date 11/09/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Statement Statement
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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