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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
Recalls CDRH Recalls
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