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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, Diagnostic
510(k) Number K023591
Device Name ULTRA HIGH PRESSURE INJECTOR LINES
Applicant
Deroyal Industries, Inc.
200 Debusk Ln.
Knoxville,  TN  37849
Applicant Contact GRACIE GREENWAY
Correspondent
Deroyal Industries, Inc.
200 Debusk Ln.
Knoxville,  TN  37849
Correspondent Contact GRACIE GREENWAY
Regulation Number870.1200
Classification Product Code
DQO  
Date Received10/25/2002
Decision Date 06/18/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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