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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 K945930
Device Name RIA LATEX CONDOM WITH SPERMICIDE, RIA COLOR CONDOM WITH SPERMICIDE
Applicant
Line One Laboratories & Trading Co.
P.O. Box 861941
Los Angeles,  CA  90086
Applicant Contact BUDIMAN LEE
Correspondent
Line One Laboratories & Trading Co.
P.O. Box 861941
Los Angeles,  CA  90086
Correspondent Contact BUDIMAN LEE
Regulation Number884.5300
Classification Product Code
HIS  
Date Received12/05/1994
Decision Date 12/19/1995
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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