K-number	K152558
Device name	Leksell Stereotactic System, Injection/ Aspiration Needle Kit
Applicant	Elekta Instrument AB
Product code	HAW
Device class	Class II
Decision date	Mar 2, 2016
Decision	Substantially Equivalent
Regulation	882.4560

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View the full FDA submission: accessdata.fda.gov

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Leksell Stereotactic System, Injection/ Aspiration Needle Kit

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