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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 K983380
Device Name DUREX LUBRAGEL LATEX CONDOM
Applicant
London Intl., LLC
2926 Columbia Hwy.
P.O. Box 8308
Dothan,  AL  36304
Applicant Contact NEIL ANDERSON
Correspondent
London Intl., LLC
2926 Columbia Hwy.
P.O. Box 8308
Dothan,  AL  36304
Correspondent Contact NEIL ANDERSON
Regulation Number884.5300
Classification Product Code
HIS  
Date Received09/25/1998
Decision Date 11/16/1998
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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