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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 K970385
Device Name SPARFLOZACIN, 5 MCG, SENSI-DISC
Applicant
Becton Dickinson Microbiology Systems
P.O. Box 243
Cockeysville,  MD  21030
Applicant Contact VIRGINIA C WEINKNECHT
Correspondent
Becton Dickinson Microbiology Systems
P.O. Box 243
Cockeysville,  MD  21030
Correspondent Contact VIRGINIA C WEINKNECHT
Regulation Number866.1620
Classification Product Code
JTN  
Date Received02/03/1997
Decision Date 03/10/1997
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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