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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 K871470
Device Name BESTCON/LUBRICATED CONDOMS
Applicant
EUROPHARMACEUTICAL CORP.
2100 SALZEDO STREET, SUITE 302
CORAL GABLES,  FL  33134
Applicant Contact LUIS B LAMAR
Correspondent
EUROPHARMACEUTICAL CORP.
2100 SALZEDO STREET, SUITE 302
CORAL GABLES,  FL  33134
Correspondent Contact LUIS B LAMAR
Regulation Number884.5300
Classification Product Code
HIS  
Date Received04/14/1987
Decision Date 08/05/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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