K-number	K020448
Device name	STATIC CRANIOPLASTY ORTHOSIS
Applicant	Eastern Cranial Affiliates
Product code	MVA
Device class	Class II
Decision date	Apr 12, 2002
Decision	Substantially Equivalent
Regulation	882.5970

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View the full FDA submission: accessdata.fda.gov

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STATIC CRANIOPLASTY ORTHOSIS

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