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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 K092586
Device Name MALE LATEX CONDOM (STRAIGHT SIDE OR CONTOURED OR FLARED IN SHAPE, EITHER TEXTURED OR NON-TEXTURED , LUBRICATED OR NON-LU
Applicant
INNOLATEX (THAILAND) LIMITED
SOUTHERN INDUSTRIAL ESTATE
VILLAGE 4 CHALUNG SUB-DISTRICT
hatyai district, songkhla,  TH 90110
Applicant Contact goh saing
Correspondent
INNOLATEX (THAILAND) LIMITED
SOUTHERN INDUSTRIAL ESTATE
VILLAGE 4 CHALUNG SUB-DISTRICT
hatyai district, songkhla,  TH 90110
Correspondent Contact goh saing
Regulation Number884.5300
Classification Product Code
HIS  
Date Received08/24/2009
Decision Date 05/12/2010
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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