Name: Predicase
Price: 199 USD

K-number	K143301
Device name	NewEra Small REVA Kit, NewEra Medium REVA Kit, NewEra Large REVA Kit
Applicant	Integrated Healing Technologies
Product code	OMP
Device class	Class II
Decision date	Mar 3, 2015
Decision	Substantially Equivalent
Regulation	878.4780

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Source

View the full FDA submission: accessdata.fda.gov

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NewEra Small REVA Kit, NewEra Medium REVA Kit, NewEra Large REVA Kit

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