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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Condom With Nonoxynol-9
510(k) Number K981955
Device Name MAXIMA, TRUSTEX, RIA AND PREMIUM EL LES CONDOMS
Applicant
Ls Rubber Sdn Bhd
11535 Park Woods Circle
Suite B
Alpharetta,  GA  30005
Applicant Contact RAJIL VOHRA
Correspondent
Ls Rubber Sdn Bhd
11535 Park Woods Circle
Suite B
Alpharetta,  GA  30005
Correspondent Contact RAJIL VOHRA
Regulation Number884.5310
Classification Product Code
LTZ  
Date Received06/04/1998
Decision Date 03/15/1999
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
Predetermined Change
Control Plan Authorized		 No
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