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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Retention Type
510(k) Number K911349
Device Name E-Z-EM ENTEROCLYSIS CATHETER SET
Applicant
E-Z-EM, INC.
717 MAIN ST.
WESTBURY,  NY  11590
Applicant Contact MERRIBETH ADAMS
Correspondent
E-Z-EM, INC.
717 MAIN ST.
WESTBURY,  NY  11590
Correspondent Contact MERRIBETH ADAMS
Regulation Number876.5980
Classification Product Code
EZK  
Date Received03/27/1991
Decision Date 11/16/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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