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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 K881100
Device Name CONDOM
Applicant
GLNIC CORP.
WORLD TRADE CENTER
350 SOUTH FIGUEROA ST. #509
LOS ANGELES,  CA  90071
Applicant Contact CHRISTINE UONG
Correspondent
GLNIC CORP.
WORLD TRADE CENTER
350 SOUTH FIGUEROA ST. #509
LOS ANGELES,  CA  90071
Correspondent Contact CHRISTINE UONG
Regulation Number884.5300
Classification Product Code
HIS  
Date Received03/15/1988
Decision Date 07/08/1988
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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