Name: Predicase
Price: 199 USD

K-number	K004003
Device name	PRO OSTEON 200R WITH CALCIUM SULFATE, MODELS 2RCS038, 2RCS050, 2RCS075, 2RCS10, 2RCS15, 2RCS20, 2RCS225, 2RCS30
Applicant	Interpore Cross Intl.
Product code	MQV
Device class	Class II
Decision date	Jul 19, 2001
Decision	Substantially Equivalent
Regulation	888.3045

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View the full FDA submission: accessdata.fda.gov

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PRO OSTEON 200R WITH CALCIUM SULFATE, MODELS 2RCS038, 2RCS050, 2RCS075, 2RCS10, 2RCS15, 2RCS20, 2RCS225, 2RCS30

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