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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, I.V. Fluid Transfer
510(k) Number K926071
Device Name ONCO-VIAL ADAPTER
Applicant
David Bull Laboratories, USA, Inc.
8777 E. Via De Ventura,
Suite 225
Scottsdale,  AZ  85258
Applicant Contact JOHN ROHRBOURGH
Correspondent
David Bull Laboratories, USA, Inc.
8777 E. Via De Ventura,
Suite 225
Scottsdale,  AZ  85258
Correspondent Contact JOHN ROHRBOURGH
Regulation Number880.5440
Classification Product Code
LHI  
Subsequent Product Code
FMI  
Date Received12/01/1992
Decision Date 02/14/1994
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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