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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 K880919
Device Name (CHOICE) ALSO (KONDUM)
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 Received03/04/1988
Decision Date 06/29/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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