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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 K032909
Device Name THAI NIPPON EXTRA STRENGTH MALE LATEX CONDOM
Applicant
THAI NIPPON RUBBER INDUSTRY CO., LTD.
1219 LITTLE CREEK RD.
durham,  NC  27713
Applicant Contact eli j carter
Correspondent
THAI NIPPON RUBBER INDUSTRY CO., LTD.
1219 LITTLE CREEK RD.
durham,  NC  27713
Correspondent Contact eli j carter
Regulation Number884.5300
Classification Product Code
HIS  
Date Received09/17/2003
Decision Date 12/16/2003
Decision substantially equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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