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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 K780350
Device Name I.V. START KIT
Applicant
Bd Becton Dickinson Vacutainer Systems Preanalytic
Washington,  DC 
Correspondent
Bd Becton Dickinson Vacutainer Systems Preanalytic
Washington,  DC 
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received03/03/1978
Decision Date 03/27/1978
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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