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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Infusion Or Syringe, Extra-Luminal
510(k) Number K932055
Device Name PERCUPUMP II
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 Number876.5820
Classification Product Code
FIH  
Date Received04/28/1993
Decision Date 03/21/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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