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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 K864482
Device Name CHOICE
Applicant
SELECT SOURCES, INC.
P.O. BOX 25B01
LOS ANGELES,  CA  90025
Applicant Contact ALLEN S FARSHI
Correspondent
SELECT SOURCES, INC.
P.O. BOX 25B01
LOS ANGELES,  CA  90025
Correspondent Contact ALLEN S FARSHI
Regulation Number884.5300
Classification Product Code
HIS  
Date Received11/13/1986
Decision Date 12/22/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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