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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 K961188
Device Name CEFEPIME, 30 MCG, SENSI-DISC
Applicant
Bd Becton Dickinson Vacutainer Systems Preanalytic
P.O. Box 243
Cockeysville,  MD  21030
Applicant Contact VIRGINIA C WEINKNECHT
Correspondent
Bd Becton Dickinson Vacutainer Systems Preanalytic
P.O. Box 243
Cockeysville,  MD  21030
Correspondent Contact VIRGINIA C WEINKNECHT
Regulation Number866.1620
Classification Product Code
JTN  
Date Received03/26/1996
Decision Date 04/05/1996
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
Recalls CDRH Recalls
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