K-number	K101422
Device name	THE POWER WAND SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER
Applicant	Access Scientific, Inc.
Product code	DYB
Device class	Class II
Decision date	Mar 22, 2011
Decision	Substantially Equivalent
Regulation	870.1340

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Source

View the full FDA submission: accessdata.fda.gov

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THE POWER WAND SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER

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