Name: Predicase
Price: 199 USD

K-number	K091202
Device name	WEDGELOC 180X STANDARD SUTURE ANCHOR WITH OPTI FIBER SUTURES,MODEL 1000-01 TAB VARYING DIAMETERS,
Applicant	Medshape Solutions
Product code	HWC
Device class	Class II
Decision date	Sep 16, 2009
Decision	Substantially Equivalent
Regulation	888.3040

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Source

View the full FDA submission: accessdata.fda.gov

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WEDGELOC 180X STANDARD SUTURE ANCHOR WITH OPTI FIBER SUTURES,MODEL 1000-01 TAB VARYING DIAMETERS,

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