K-number	K895842
Device name	BITOME(TM) BIPOLAR SPHINCTEROTOME
Applicant	Everest Medical Corp.
Product code	KNS
Device class	Class II
Decision date	Jan 11, 1990
Decision	Substantially Equivalent
Regulation	876.4300

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View the full FDA submission: accessdata.fda.gov

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BITOME(TM) BIPOLAR SPHINCTEROTOME

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