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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 K854622
Device Name PROPHYLACTIC (CONDOM)
Applicant
Medelec Intl. Corp.
One Lincoln Rd., Suite 304
Miami Beach,  FL  33139
Applicant Contact OSCAR D DOCAL
Correspondent
Medelec Intl. Corp.
One Lincoln Rd., Suite 304
Miami Beach,  FL  33139
Correspondent Contact OSCAR D DOCAL
Regulation Number884.5300
Classification Product Code
HIS  
Date Received11/18/1985
Decision Date 04/11/1986
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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