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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Administration, Intravascular
510(k) Number K885264
Device Name WINGED INFUSION SET
Applicant
E-Z-Em, Inc.
717 Main St.
Westbury,  NY  11590
Applicant Contact JACK T BERGER
Correspondent
E-Z-Em, Inc.
717 Main St.
Westbury,  NY  11590
Correspondent Contact JACK T BERGER
Regulation Number880.5440
Classification Product Code
FPA  
Date Received12/22/1988
Decision Date 01/31/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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