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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 K080998
Device Name DORIPENEM 10UG BBL SENSI-DISC
Applicant
BECTON DICKINSON & CO.
7 LOVETON CIR.
SPARKS,  MD  21152
Applicant Contact JANINE MATLAK
Correspondent
BECTON DICKINSON & CO.
7 LOVETON CIR.
SPARKS,  MD  21152
Correspondent Contact JANINE MATLAK
Regulation Number866.1620
Classification Product Code
JTN  
Date Received04/07/2008
Decision Date 05/12/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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