K-number	K011350
Device name	STARBAND CRANIAL ORTHOSIS
Applicant	Orthomerica Products, Inc.
Product code	OAN
Device class	Class II
Decision date	Jul 3, 2001
Decision	Substantially Equivalent
Regulation	882.5970

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View the full FDA submission: accessdata.fda.gov

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STARBAND CRANIAL ORTHOSIS

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