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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Condom With Nonoxynol-9
510(k) Number K010178
Device Name SPERMICIDAL LUBRICATED MALE LATEX CONDOM
Applicant
Innolatex Sdn. Bhd
# 16, Jalan Bulan U5/5,
Bandar Pinggiran Subang
Shah Alam, Selangor D.E.,  MY 40150
Applicant Contact CHANG AU-KAU
Correspondent
Innolatex Sdn. Bhd
# 16, Jalan Bulan U5/5,
Bandar Pinggiran Subang
Shah Alam, Selangor D.E.,  MY 40150
Correspondent Contact CHANG AU-KAU
Regulation Number884.5310
Classification Product Code
LTZ  
Date Received01/19/2001
Decision Date 04/27/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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