K-number	K944382
Device name	ORION ALL SILICONE FOLEY CATHETER
Applicant	Regulatory & Marketing Services, Inc.
Product code	EZL
Device class	Class II
Decision date	Dec 6, 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 FOLEY CATHETER

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