Name: Predicase
Price: 199 USD

K-number	K133625
Device name	AGILITY 10 STANDARD & SOFT 0.01IN. X 195CM, AGILITY 14 STANDARD & SOFT 0.014IN X 205CM & XL 350CM, AGILITY 16 STANDARD &
Applicant	Codman & Shurtleff, Inc.
Product code	MOF
Device class	Class II
Decision date	Feb 24, 2014
Decision	Substantially Equivalent
Regulation	870.1330

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Source

View the full FDA submission: accessdata.fda.gov

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AGILITY 10 STANDARD & SOFT 0.01IN. X 195CM, AGILITY 14 STANDARD & SOFT 0.014IN X 205CM & XL 350CM, AGILITY 16 STANDARD &

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