K-number	K051515
Device name	MODIFIED ACUMEN SHEATH, MODEL TTW 10-65
Applicant	Acumen Medical, Inc.
Product code	DYB
Device class	Class II
Decision date	Sep 1, 2005
Decision	Substantially Equivalent
Regulation	870.1340

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View the full FDA submission: accessdata.fda.gov

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MODIFIED ACUMEN SHEATH, MODEL TTW 10-65

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