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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 K012664
Device Name ULTRA THICK MALE LATEX CONDOM WITH SILICONE LUBRICANT
Applicant
INNOLATEX SDN. BHD
NO 16, JALAN BULAN U5/5
BANDAR PINGGIRAN SUBANG,
SHAH ALAM,SELANGOR DARUL EHSAN,  MY
Applicant Contact CHANG AH-KAU
Correspondent
INNOLATEX SDN. BHD
NO 16, JALAN BULAN U5/5
BANDAR PINGGIRAN SUBANG,
SHAH ALAM,SELANGOR DARUL EHSAN,  MY
Correspondent Contact CHANG AH-KAU
Regulation Number884.5300
Classification Product Code
HIS  
Date Received08/13/2001
Decision Date 11/09/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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