Name: Predicase
Price: 199 USD

K-number	K952884
Device name	NOPROFILE OLBERT CATHETER SYSTEM BALLOON DILATATION CATHETER
Applicant	Meadox Medicals, Div. Boston Scientific Corp.
Product code	LIT
Device class	Class II
Decision date	Feb 21, 1996
Decision	Substantially Equivalent
Regulation	870.1250

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View the full FDA submission: accessdata.fda.gov

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NOPROFILE OLBERT CATHETER SYSTEM BALLOON DILATATION CATHETER

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