K-number	K944376
Device name	ORION ALL SILICONE ELASTOMER COATED CATHETER
Applicant	Regulatory & Marketing Services, Inc.
Product code	EZL
Device class	Class II
Decision date	Nov 30, 1994
Decision	Substantially Equivalent
Regulation	876.5130

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View the full FDA submission: accessdata.fda.gov

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ORION ALL SILICONE ELASTOMER COATED CATHETER

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