Name: Predicase
Price: 199 USD

K-number	K191498
Device name	Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set with Mac-Loc, Ultrathane Suprapubic Set with Mac-Loc
Applicant	Cook Incorporated
Product code	LJE
Device class	Class U
Decision date	Jan 29, 2020
Decision	Unknown
Regulation	—

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Source

View the full FDA submission: accessdata.fda.gov

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Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set with Mac-Loc, Ultrathane Suprapubic Set with Mac-Loc

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