K-number	K972439
Device name	ANORECTAL MANOMETRY ANALYSIS MODULE
Applicant	Medtronic-Synectics
Product code	FFX
Device class	Class II
Decision date	Sep 23, 1997
Decision	Substantially Equivalent
Regulation	876.1725

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View the full FDA submission: accessdata.fda.gov

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ANORECTAL MANOMETRY ANALYSIS MODULE

Everything you need for a 510(k) submission. Nothing you don't.