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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 K991049
Device Name CLIMAX
Applicant
MEDILATEX SDN. BHD.
LOT PTB 500, PERINDUSTRIAN
PKT2, BANDAR TENGGARA
KULAI, JOHOR,  MY 81000
Applicant Contact LEE KIM LANG
Correspondent
MEDILATEX SDN. BHD.
LOT PTB 500, PERINDUSTRIAN
PKT2, BANDAR TENGGARA
KULAI, JOHOR,  MY 81000
Correspondent Contact LEE KIM LANG
Regulation Number884.5300
Classification Product Code
HIS  
Date Received03/30/1999
Decision Date 06/15/1999
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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