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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
Original Applicant
DEROYAL INDUSTRIES, INC.
200 debusk ln.
powell,  TN  37849
Original Contact gracie greenway
Regulation Number870.1200
Classification Product Code
DQO  
Date Received10/25/2002
Decision Date 06/18/2003
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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