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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lubricant, Personal
510(k) Number K150743
Device Name Water Based Personal Lubricant with Flavours
Applicant
KAREX INDUSTRIES SDN. BHD.
PTD 7906 & 7907, TAMAN PONTIAN JAYA, BATU 34, JALAN JOHOR
PONTIAN,  MY 82000
Applicant Contact MS. MARY GOH YIN
Correspondent
KAREX INDUSTRIES SDN. BHD.
PTD 7906 & 7907, TAMAN PONTIAN JAYA, BATU 34, JALAN JOHOR
PONTIAN,  MY 82000
Correspondent Contact MS. MARY GOH YIN
Regulation Number884.5300
Classification Product Code
NUC  
Date Received03/23/2015
Decision Date 11/12/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Statement Statement
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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