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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 K923952
Device Name ENOXACIN 10 MCG. SENSI SISC
Applicant
Becton Dickinson Microbiology Systems
P.O. Box 243
Cockeysville,  MD  21030
Applicant Contact ROBERT E JAMES
Correspondent
Becton Dickinson Microbiology Systems
P.O. Box 243
Cockeysville,  MD  21030
Correspondent Contact ROBERT E JAMES
Regulation Number866.1620
Classification Product Code
JTN  
Date Received08/06/1992
Decision Date 09/18/1992
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
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