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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
Applicant Contact MARTIN S KNOPF
Correspondent
E-Z-EM, INC.
28 MARIGOLD LN.
MARLBORO,  NJ  07746
Correspondent Contact MARTIN S KNOPF
Regulation Number870.1200
Classification Product Code
DQO  
Date Received01/17/1989
Decision Date 05/19/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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