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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 K862401
Device Name PERSONAL/DERBY CONDOMS
Applicant
Razi Corp.
P.O. Box 755
Manhasset,  NY  11030
Applicant Contact DANY TUBIAN
Correspondent
Razi Corp.
P.O. Box 755
Manhasset,  NY  11030
Correspondent Contact DANY TUBIAN
Regulation Number884.5300
Classification Product Code
HIS  
Date Received06/25/1986
Decision Date 03/04/1987
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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