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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 K884325
Device Name SUBCLAVIAN HEMODIALYSIS CATH. W/VITACUFF DEVICE
Applicant
Bd Becton Dickinson Vacutainer Systems Preanalytic
9450 S. State Sreet
Sandy,  UT  84070
Applicant Contact CHARLES J WELLE
Correspondent
Bd Becton Dickinson Vacutainer Systems Preanalytic
9450 S. State Sreet
Sandy,  UT  84070
Correspondent Contact CHARLES J WELLE
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received10/14/1988
Decision Date 04/25/1989
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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