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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 K970633
Device Name TUSTEX FLAVORED CONDOMS
Applicant
Line One Laboratories
121 W. Elmyra St.
Los Angeles,  CA  90012
Applicant Contact ROBERT GRUBER
Correspondent
Line One Laboratories
121 W. Elmyra St.
Los Angeles,  CA  90012
Correspondent Contact ROBERT GRUBER
Regulation Number884.5300
Classification Product Code
HIS  
Date Received02/20/1997
Decision Date 03/21/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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