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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Injector And Syringe, Angiographic
510(k) Number K910594
Device Name TRAC-WRIGHT SYSTEM, MODEL TW2
Applicant
Dow Corning Wright
P.O. Box 100
Arlington,  TN  38002
Applicant Contact MCGURK BURLESON
Correspondent
Dow Corning Wright
P.O. Box 100
Arlington,  TN  38002
Correspondent Contact MCGURK BURLESON
Regulation Number870.1650
Classification Product Code
DXT  
Date Received02/12/1991
Decision Date 09/23/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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