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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 K000762
Device Name MOXIFLOXACIN, 5 UG, BBL SENSI-DISC
Applicant
Bd Becton Dickinson Vacutainer Systems Preanalytic
7 Loveton Circle
Sparks,  MD  21152 -0999
Applicant Contact BRADFORD SPRING
Correspondent
Bd Becton Dickinson Vacutainer Systems Preanalytic
7 Loveton Circle
Sparks,  MD  21152 -0999
Correspondent Contact BRADFORD SPRING
Regulation Number866.1620
Classification Product Code
JTN  
Date Received03/08/2000
Decision Date 04/25/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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