Name: Predicase
Price: 199 USD

K-number	K080918
Device name	DOUBLE ARMED MENISCAL NEEDLES WITH SIZE #2-0 ORTHOCORD, MENISCAL NEEDLE WITH WIRE EYELET & 3 FREE STRANDS OF SIZE #2-0
Applicant	Depuy Mitek
Product code	NEW
Device class	Class II
Decision date	Apr 23, 2008
Decision	Substantially Equivalent
Regulation	878.4840

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Source

View the full FDA submission: accessdata.fda.gov

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DOUBLE ARMED MENISCAL NEEDLES WITH SIZE #2-0 ORTHOCORD, MENISCAL NEEDLE WITH WIRE EYELET & 3 FREE STRANDS OF SIZE #2-0

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