K-number	K030854
Device name	PROTOCO2L COLON INSUFFLATOR WITH PERFORMANCE IMPROVEMENTS, MODEL 6400
Applicant	E-Z-Em, Inc.
Product code	FCX
Device class	Class II
Decision date	Apr 16, 2003
Decision	Substantially Equivalent
Regulation	876.1500

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PROTOCO2L COLON INSUFFLATOR WITH PERFORMANCE IMPROVEMENTS, MODEL 6400

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