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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Insufflator, Automatic Carbon-Dioxide For Endoscope
510(k) Number K053008
Device Name E-Z-EM ENDOSCOPIC CO2 REGULATOR
Applicant
E-Z-Em, Inc.
750 Summa Ave.
Westbury,  NY  11590
Applicant Contact ROBERT WILLIAMS
Correspondent
E-Z-Em, Inc.
750 Summa Ave.
Westbury,  NY  11590
Correspondent Contact ROBERT WILLIAMS
Regulation Number876.1500
Classification Product Code
FCX  
Date Received10/26/2005
Decision Date 12/27/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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