Name: Predicase
Price: 199 USD

K-number	K111629
Device name	TURON RSP SOCKET SHELL-NEUTRAL MODEL 508-02-000, TURON RSP SOCKET SHELL-OFFSET MODEL 508-02-001
Applicant	Encore Medical L.P.
Product code	PHX
Device class	Class II
Decision date	Sep 16, 2011
Decision	Substantially Equivalent
Regulation	888.3660

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Source

View the full FDA submission: accessdata.fda.gov

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TURON RSP SOCKET SHELL-NEUTRAL MODEL 508-02-000, TURON RSP SOCKET SHELL-OFFSET MODEL 508-02-001

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