K-number	K061532
Device name	GENTLE COLON (REVISION 2.0)
Applicant	Rendoscopy, Inc.
Product code	LLZ
Device class	Class II
Decision date	Sep 18, 2006
Decision	Substantially Equivalent
Regulation	892.2050

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View the full FDA submission: accessdata.fda.gov

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GENTLE COLON (REVISION 2.0)

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