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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 K991892
Device Name TRUSTEX MINT FLAVORED CONDOM IN GREEN COLOR, IMPULSE MINT FLAVORED CONDOM IN GREEN COLOR
Applicant
Line One Laboratories
1481 E. 4th St.
Los Angeles,  CA  90033
Applicant Contact ROBERT GRUBER
Correspondent
Line One Laboratories
1481 E. 4th St.
Los Angeles,  CA  90033
Correspondent Contact ROBERT GRUBER
Regulation Number884.5300
Classification Product Code
HIS  
Date Received06/03/1999
Decision Date 08/19/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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