K-number	K011433
Device name	BALLERT CRANIAL MOLDING HELMET
Applicant	Gema, Inc.
Product code	MVA
Device class	Class II
Decision date	Jun 12, 2001
Decision	Substantially Equivalent
Regulation	882.5970

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View the full FDA submission: accessdata.fda.gov

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BALLERT CRANIAL MOLDING HELMET

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