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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 K890206
Device Name E-Z-FLOW ANGIOGRAPHY CATHETERS
Applicant
E-Z-EM, INC.
28 marigold ln.
marlboro,  NJ  07746
Contact martin s knopf
Regulation Number870.1200
Classification Product Code
DQO  
Date Received01/17/1989
Decision Date 05/19/1989
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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