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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 K980319
Device Name DUREX ULTRA COMFORT
Applicant
LONDON INTL. LLC.
2926 COLUMBIA HWY.
P.O. BOX 8308
DOTHAN,  AL  36304
Applicant Contact NEIL ANDERSON, RAC
Correspondent
LONDON INTL. LLC.
2926 COLUMBIA HWY.
P.O. BOX 8308
DOTHAN,  AL  36304
Correspondent Contact NEIL ANDERSON, RAC
Regulation Number884.5300
Classification Product Code
HIS  
Date Received01/27/1998
Decision Date 05/20/1998
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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