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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 K880819
Device Name CONDOMS
Applicant
UNIVERSAL TRADE, INC.
22 WEST PUTNAM AVE.
GREENWICH,  CT  06830
Applicant Contact EDWARD J AARON
Correspondent
UNIVERSAL TRADE, INC.
22 WEST PUTNAM AVE.
GREENWICH,  CT  06830
Correspondent Contact EDWARD J AARON
Regulation Number884.5300
Classification Product Code
HIS  
Date Received02/26/1988
Decision Date 08/11/1989
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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