Name: Predicase
Price: 199 USD

K-number	K232130
Device name	Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheter
Applicant	Surgical Instrument Services and Savings, Inc.
Product code	OWQ
Device class	Class II
Decision date	Dec 15, 2023
Decision	Substantially Equivalent
Regulation	870.1200

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Source

View the full FDA submission: accessdata.fda.gov

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Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheter

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