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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 K230651
Device Name BD BBL™ Sensi-Disc™ Lefamulin 20µg (LMU-20)
Applicant
Becton, Dickinson and Company
7 Loveton Circle
Sparks,  MD  21152 -0999
Applicant Contact Katherine Cicala
Correspondent
Becton, Dickinson and Company
7 Loveton Circle
Sparks,  MD  21152 -0999
Correspondent Contact Katherine Cicala
Regulation Number866.1620
Classification Product Code
JTN  
Date Received03/09/2023
Decision Date 06/07/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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