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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 K993577
Device Name CEFOTAXIME/CLAVULANIC, 30/10UG, BBL SENSI-DISC AND CEFTAZIDIME/CLAVULANIC ACID, 30/10UG, BBL SENSI-DISC
Applicant
Becton Dickinson Microbiology Systems
7loveton Cir.
Sparks,  MD  21152
Applicant Contact MONICA E GIGUERE
Correspondent
Becton Dickinson Microbiology Systems
7loveton Cir.
Sparks,  MD  21152
Correspondent Contact MONICA E GIGUERE
Regulation Number866.1620
Classification Product Code
JTN  
Date Received10/21/1999
Decision Date 12/01/1999
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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