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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Holder, Syringe, Lead
510(k) Number K863936
Device Name DUFFY BOLUS INJECTOR
Applicant
Viox Corp.
6701 Sixth Ave. S.
Seattle,  WA  98108
Applicant Contact THOMAS W BURNETT
Correspondent
Viox Corp.
6701 Sixth Ave. S.
Seattle,  WA  98108
Correspondent Contact THOMAS W BURNETT
Regulation Number892.6500
Classification Product Code
IWR  
Date Received10/09/1986
Decision Date 01/06/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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