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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Continuous Flush
510(k) Number K905447
Device Name E-Z-EM PULSED INFUSION SYSTEM
Applicant
E-Z-Em, Inc.
373 Plantation St.
Worcester,  MA  01605
Applicant Contact GEORGANNE BROWN
Correspondent
E-Z-Em, Inc.
373 Plantation St.
Worcester,  MA  01605
Correspondent Contact GEORGANNE BROWN
Regulation Number870.1210
Classification Product Code
KRA  
Date Received12/05/1990
Decision Date 04/01/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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