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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name barrier, std, oral sex
510(k) Number K091769
Device Name TRUST DAM
Applicant
LINE ONE LABORATORIES, INC.
PO BOX 12139
DURHAM,  NC  27709
Applicant Contact ELI J CARTER
Correspondent
LINE ONE LABORATORIES, INC.
PO BOX 12139
DURHAM,  NC  27709
Correspondent Contact ELI J CARTER
Regulation Number884.5300
Classification Product Code
MSC  
Date Received06/16/2009
Decision Date 02/05/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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