K-number	DEN080006
Device name	ULTHERA SYSTEM, MODEL 8850-0001
Applicant	Ulthera, Inc.
Product code	OHV
Device class	Class II
Decision date	Sep 11, 2009
Decision	Not Substantially Equivalent
Regulation	878.4590

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View the full FDA submission: accessdata.fda.gov

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ULTHERA SYSTEM, MODEL 8850-0001

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