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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, intravascular, therapeutic, long-term greater than 30 days
510(k) Number K091670
Device Name BD L-CATH SINGLE AND DUAL LUMENT CATHETERS, MIDLINE CATHETER
Applicant
BECTON DICKINSON & CO.
9450 SOUTH STATE STREET
SANDY,  UT  84070
Applicant Contact JUSTICE ALDER
Correspondent
BECTON DICKINSON & CO.
9450 SOUTH STATE STREET
SANDY,  UT  84070
Correspondent Contact JUSTICE ALDER
Regulation Number880.5970
Classification Product Code
LJS  
Subsequent Product Code
FOZ  
Date Received06/09/2009
Decision Date 07/01/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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