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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 K980174
Device Name DUREX COLORS AND SCENTS
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 Received01/20/1998
Decision Date 08/13/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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