K-number	K083423
Device name	COLONCAD API 3.1
Applicant	Medicsight Plc
Product code	NWE
Device class	Class II
Decision date	May 17, 2011
Decision	Substantially Equivalent
Regulation	892.2050

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Source

View the full FDA submission: accessdata.fda.gov

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COLONCAD API 3.1

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