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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 K980683
Device Name TROVAFLOXACIN 10G, SENSI-DISC
Applicant
Becton Dickinson Microbiology Systems
7loveton Cir.
Sparks,  MD  21152
Applicant Contact VIRGINIA C WEINKNECHT
Correspondent
Becton Dickinson Microbiology Systems
7loveton Cir.
Sparks,  MD  21152
Correspondent Contact VIRGINIA C WEINKNECHT
Regulation Number866.1620
Classification Product Code
JTN  
Date Received02/23/1998
Decision Date 05/01/1998
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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