Name: Predicase
Price: 199 USD

K-number	K160077
Device name	RetroPerc Flexible Ureteroscopy-Guided Retrograde Nephrostomy Wire Puncture Set
Applicant	Jbw7 Innovations, LLC
Product code	LJE
Device class	Class U
Decision date	Jul 12, 2016
Decision	Substantially Equivalent
Regulation	—

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Source

View the full FDA submission: accessdata.fda.gov

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RetroPerc Flexible Ureteroscopy-Guided Retrograde Nephrostomy Wire Puncture Set

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