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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Susceptibility Test Discs, Antimicrobial
510(k) Number K052853
Device Name TIGECYCLINE 15UG BBL SENSI-DISC
Applicant
Becton, Dickinson & CO
7loveton Cir
Sparks,  MD  21152
Applicant Contact DAINELLE CLARK
Correspondent
Becton, Dickinson & CO
7loveton Cir
Sparks,  MD  21152
Correspondent Contact DAINELLE CLARK
Regulation Number866.1620
Classification Product Code
JTN  
Date Received10/11/2005
Decision Date 11/17/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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