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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 K964598
Device Name TRUSTEX COLA FLAVORD CONDOM
Applicant
LINE ONE LABORATORIES
1481 EAST 4TH ST.
LOS ANGELES,  CA  90033
Applicant Contact ROBERT GRUBER
Correspondent
LINE ONE LABORATORIES
1481 EAST 4TH ST.
LOS ANGELES,  CA  90033
Correspondent Contact ROBERT GRUBER
Regulation Number884.5300
Classification Product Code
HIS  
Date Received11/18/1996
Decision Date 02/14/1997
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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