Name: Predicase
Price: 199 USD

K-number	K965228
Device name	FASTERNER, FIXATION, BIODEGRADABLE SOFT TISSUE
Applicant	United States Surgical, A Division of Tyco Healthc
Product code	MAI
Device class	Class II
Decision date	Nov 10, 1997
Decision	Substantially Equivalent
Regulation	888.3030

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Source

View the full FDA submission: accessdata.fda.gov

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FASTERNER, FIXATION, BIODEGRADABLE SOFT TISSUE

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