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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 K974578
Device Name GREPAFLOXACIN, 5 MG, SENSI-DISC
Applicant
Becton Dickinson Microbiology Systems
7 Loveton Cir.
Sparks,  MD  21152 -0999
Applicant Contact VIRGINIA C WEINKNECHT
Correspondent
Becton Dickinson Microbiology Systems
7 Loveton Cir.
Sparks,  MD  21152 -0999
Correspondent Contact VIRGINIA C WEINKNECHT
Regulation Number866.1620
Classification Product Code
JTN  
Date Received12/08/1997
Decision Date 02/23/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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