Name: Predicase
Price: 199 USD

K-number	K041806
Device name	PASSING NEEDLE WITH ETHIBOND, PANACRYL OR ORTHOCORD SUTURE; AND PASSING NEEDLE WITH ETHIBOND LOOP
Applicant	Depuy Mitek, A Johnson & Johnson Company
Product code	GAM
Device class	Class II
Decision date	Aug 3, 2004
Decision	Substantially Equivalent
Regulation	878.4493

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Source

View the full FDA submission: accessdata.fda.gov

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PASSING NEEDLE WITH ETHIBOND, PANACRYL OR ORTHOCORD SUTURE; AND PASSING NEEDLE WITH ETHIBOND LOOP

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