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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 K113061
Device Name LARGE/EXTRA LAGRE CONDOM
Applicant
KAREX INDUSTRIES SDN BHD.
PTD. 7906 & 7907, TAMAN
PONTIAN JAYA, BT 34
johor darul takzim,  MY 82000
Applicant Contact lai peng
Correspondent
KAREX INDUSTRIES SDN BHD.
PTD. 7906 & 7907, TAMAN
PONTIAN JAYA, BT 34
johor darul takzim,  MY 82000
Correspondent Contact lai peng
Regulation Number884.5300
Classification Product Code
HIS  
Date Received10/14/2011
Decision Date 12/07/2011
Decision substantially equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
statement statement
Type Special
Reviewed by Third Party No
Combination Product No
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