K-number	K150789
Device name	SPINAUT-E, SPINAUT-I
Applicant	Imedicom Co., Ltd.
Product code	BSO
Device class	Class II
Decision date	Mar 1, 2016
Decision	Substantially Equivalent
Regulation	868.5120

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View the full FDA submission: accessdata.fda.gov

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SPINAUT-E, SPINAUT-I

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