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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 K896107
Device Name RUBBER CONTRACEPTIVE
Applicant
BANRUB SDN BHD
15-A, JALAN PETALING, LARKIN
INDUSTRIAL ESTATE, 80350
JOHOR BAHRU, J.D.T.,  MY
Applicant Contact GOH SIANG
Correspondent
BANRUB SDN BHD
15-A, JALAN PETALING, LARKIN
INDUSTRIAL ESTATE, 80350
JOHOR BAHRU, J.D.T.,  MY
Correspondent Contact GOH SIANG
Regulation Number884.5300
Classification Product Code
HIS  
Date Received10/23/1989
Decision Date 06/29/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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