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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, Short-Term Less Than 30 Days
510(k) Number K972254
Device Name FIRST MIDCATH CATHETER
Applicant
BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC.
9450 SOUTH STATE ST.
SANDY,  UT  84070
Applicant Contact C.J. WELLE
Correspondent
BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC.
9450 SOUTH STATE ST.
SANDY,  UT  84070
Correspondent Contact C.J. WELLE
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received06/16/1997
Decision Date 09/12/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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