K-number	K982557
Device name	BARD PROFORMA AND APOLLO PRE-CURVED PAPILLOTOMES
Applicant	Bard Interventional Products Div.
Product code	KNS
Device class	Class II
Decision date	Sep 10, 1998
Decision	Substantially Equivalent
Regulation	876.4300

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View the full FDA submission: accessdata.fda.gov

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BARD PROFORMA AND APOLLO PRE-CURVED PAPILLOTOMES

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