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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 K012653
Device Name MALE LATEX CONDOM
Applicant
QINGDAO SHUANG DIE LATEX PRODUCTION CO.,LTD
1219 LITTLE CREEK RD.
DURHAM,  NC  27713
Applicant Contact ELI J CARTER
Correspondent
QINGDAO SHUANG DIE LATEX PRODUCTION CO.,LTD
1219 LITTLE CREEK RD.
DURHAM,  NC  27713
Correspondent Contact ELI J CARTER
Regulation Number884.5300
Classification Product Code
HIS  
Date Received08/13/2001
Decision Date 09/21/2001
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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