K-number	K002847
Device name	INTRODUCER WITH DISTAL RADIOPAQUE MARKER BAND, MODEL OR-4926XX
Applicant	Maxxim Medical
Product code	DYB
Device class	Class II
Decision date	May 31, 2001
Decision	Substantially Equivalent
Regulation	870.1340

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View the full FDA submission: accessdata.fda.gov

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INTRODUCER WITH DISTAL RADIOPAQUE MARKER BAND, MODEL OR-4926XX

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