Name: Predicase
Price: 199 USD

K-number	K083855
Device name	MODIFIED ACUMEN LEAD DELIVERY SHEATH WITH STYLET, MODEL: SPIRIT-10.5-59
Applicant	Acumen Medical, Inc.
Product code	DYB
Device class	Class II
Decision date	Feb 17, 2009
Decision	Substantially Equivalent
Regulation	870.1340

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Source

View the full FDA submission: accessdata.fda.gov

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MODIFIED ACUMEN LEAD DELIVERY SHEATH WITH STYLET, MODEL: SPIRIT-10.5-59

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