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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 K002393
Device Name NON-SPERMICIDAL LUBRICATED MALE LATEX CONDOM
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 Received08/07/2000
Decision Date 12/19/2000
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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