K-number	K102460
Device name	AMBIT INTRODUCER, AMBIT NEEDLE, AMBIT SHEATH
Applicant	Summit Medical Products, Inc.
Product code	BSO
Device class	Class II
Decision date	Jan 13, 2011
Decision	Substantially Equivalent
Regulation	868.5120

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Source

View the full FDA submission: accessdata.fda.gov

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AMBIT INTRODUCER, AMBIT NEEDLE, AMBIT SHEATH

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