Name: Predicase
Price: 199 USD

K-number	K080500
Device name	MODIFICATION TO: ACUMEN SINGLE-LUMEN DELIVERY SHEATH, MODELS BLS-10, BLS-9, BLS-7
Applicant	Acumen Medical, Inc.
Product code	DYB
Device class	Class II
Decision date	Mar 13, 2008
Decision	Substantially Equivalent
Regulation	870.1340

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View the full FDA submission: accessdata.fda.gov

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MODIFICATION TO: ACUMEN SINGLE-LUMEN DELIVERY SHEATH, MODELS BLS-10, BLS-9, BLS-7

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