K-number	K131300
Device name	THE POWERWAND SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER
Applicant	Access Scientific, LLC
Product code	DYB
Device class	Class II
Decision date	Jun 7, 2013
Decision	Substantially Equivalent
Regulation	870.1340

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Source

View the full FDA submission: accessdata.fda.gov

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THE POWERWAND SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER

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