K-number	K111247
Device name	CRANIAL REMOLDING ORTHOSIS
Applicant	Orthotic Care Services, Llp
Product code	MVA
Device class	Class II
Decision date	Aug 15, 2011
Decision	Substantially Equivalent
Regulation	882.5970

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Source

View the full FDA submission: accessdata.fda.gov

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CRANIAL REMOLDING ORTHOSIS

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