K-number	K053008
Device name	E-Z-EM ENDOSCOPIC CO2 REGULATOR
Applicant	E-Z-Em, Inc.
Product code	FCX
Device class	Class II
Decision date	Dec 27, 2005
Decision	Substantially Equivalent
Regulation	876.1500

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View the full FDA submission: accessdata.fda.gov

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E-Z-EM ENDOSCOPIC CO2 REGULATOR

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