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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 K924797
Device Name CEFPODOXIME 10 MCG, SENSI DISC
Applicant
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
P.O. BOX 243
COCKEYSVILLE,  MD  21030 -0243
Applicant Contact ROBERT E JAMES
Correspondent
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
P.O. BOX 243
COCKEYSVILLE,  MD  21030 -0243
Correspondent Contact ROBERT E JAMES
Regulation Number866.1620
Classification Product Code
JTN  
Date Received09/24/1992
Decision Date 11/02/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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