Name: Predicase
Price: 199 USD

K-number	K091900
Device name	ABSORBATACK 5MM SINGLE USE ABSORBABLE FIXATION DEVICE
Applicant	Covidien Lp, Formerly Registered AS United States
Product code	GDW
Device class	Class II
Decision date	Jul 16, 2009
Decision	Substantially Equivalent
Regulation	878.4750

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Source

View the full FDA submission: accessdata.fda.gov

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ABSORBATACK 5MM SINGLE USE ABSORBABLE FIXATION DEVICE

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