Name: Predicase
Price: 199 USD

K-number	K182828
Device name	Medline ReNewal Reprocessed Carter-Thomason Needle Point Suture Passer
Applicant	Surgical Instrument Service and Savings, Inc.
Product code	NLM
Device class	Class II
Decision date	Apr 15, 2019
Decision	Substantially Equivalent
Regulation	876.1500

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Source

View the full FDA submission: accessdata.fda.gov

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Medline ReNewal Reprocessed Carter-Thomason Needle Point Suture Passer

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