Name: Predicase
Price: 199 USD

K-number	K162322
Device name	the POWERWAND Safety Introducer with an Extended Dwell Catheter, 3Fr. Model
Applicant	Access Scientific, LLC
Product code	DYB
Device class	Class II
Decision date	Nov 17, 2016
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, 3Fr. Model

Everything you need for a 510(k) submission. Nothing you don't.