K-number	K123354
Device name	REVITIVE IX
Applicant	Actegy , Ltd.
Product code	IPF
Device class	Class II
Decision date	Jun 28, 2013
Decision	Substantially Equivalent
Regulation	890.5850

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Source

View the full FDA submission: accessdata.fda.gov

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REVITIVE IX

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