K-number	K110947
Device name	APEX K1 HIP STEM
Applicant	Omni Life Science, Inc.
Product code	LPH
Device class	Class II
Decision date	Jun 16, 2011
Decision	Substantially Equivalent
Regulation	888.3358

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Source

View the full FDA submission: accessdata.fda.gov

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APEX K1 HIP STEM

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