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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 K070511
Device Name RICHTER MALE LATEX CONDOM
Applicant
Richter Rubber Technology Sbn Bhd
P.O. Box 12139
Durham,  NC  27709
Applicant Contact SUBRAMANIAM NARAYANASAMY
Correspondent
Richter Rubber Technology Sbn Bhd
P.O. Box 12139
Durham,  NC  27709
Correspondent Contact SUBRAMANIAM NARAYANASAMY
Regulation Number884.5300
Classification Product Code
HIS  
Date Received02/22/2007
Decision Date 01/14/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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