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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 K994118
Device Name OSMANTHUS, KONGFU, AND GOBON, NATURAL RUBBER LATEX CONDOMS
Applicant
Guilin Latex Factory
93 Morningside Dr.
San Francisco,  CA  94132
Applicant Contact PETER WEI
Correspondent
Guilin Latex Factory
93 Morningside Dr.
San Francisco,  CA  94132
Correspondent Contact PETER WEI
Regulation Number884.5300
Classification Product Code
HIS  
Date Received12/06/1999
Decision Date 08/14/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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