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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 K944786
Device Name RIA LATEX CONDOM & RIA COLOR CONDOMS (RED, GREEN, BLUE, ORANGE, PURPLE AND BLACK)
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 Received09/28/1994
Decision Date 12/06/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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