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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 K871451
Device Name BESTCON/SPERMICIDE
Applicant
Europharmaceutical Corp.
2100 Salzedo St., Suite 302
Coral Gables,  FL  33134
Applicant Contact LUIS B LAMAR
Correspondent
Europharmaceutical Corp.
2100 Salzedo St., Suite 302
Coral Gables,  FL  33134
Correspondent Contact LUIS B LAMAR
Regulation Number884.5300
Classification Product Code
HIS  
Date Received04/13/1987
Decision Date 12/08/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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