Name: Predicase
Price: 199 USD

K-number	K112876
Device name	CUFFLINK(TM) KNOTLESS ANCHOR WITH INSERTER, 4.5MM/5.5MM - PEEK ONLY, CUFFLINK SP(TM) KNOTLESS ANCHOR WITH INSERTER, 4.5
Applicant	Cayenne Medical, Inc.
Product code	MBI
Device class	Class II
Decision date	Dec 15, 2011
Decision	Substantially Equivalent
Regulation	888.3040

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Source

View the full FDA submission: accessdata.fda.gov

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CUFFLINK(TM) KNOTLESS ANCHOR WITH INSERTER, 4.5MM/5.5MM - PEEK ONLY, CUFFLINK SP(TM) KNOTLESS ANCHOR WITH INSERTER, 4.5

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