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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 K860909
Device Name WORLDS BEST AND WORLDS BEST EXTRA SERIES (CONDOMS)
Applicant
U. C. Import & Co.
P.O. Box 6161
Beverly Hills,  PA  90212
Applicant Contact MAX NAAMI
Correspondent
U. C. Import & Co.
P.O. Box 6161
Beverly Hills,  PA  90212
Correspondent Contact MAX NAAMI
Regulation Number884.5300
Classification Product Code
HIS  
Date Received03/10/1986
Decision Date 08/19/1986
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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