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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 K000235
Device Name INSYTE CATHETER, INSYTE AUTOGUARD CATHETER
Applicant
Becton Dickinson Infusion Therapy Systems, Inc.
9450 S St.ate St.
Sandy,  UT  84070
Applicant Contact LESLIE WOOD
Correspondent
Becton Dickinson Infusion Therapy Systems, Inc.
9450 S St.ate St.
Sandy,  UT  84070
Correspondent Contact LESLIE WOOD
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received01/27/2000
Decision Date 04/05/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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