K-number	K012830
Device name	LERMAN & SON CRANIAL ORTHOSIS HELMET
Applicant	Lerman & Son
Product code	MVA
Device class	Class II
Decision date	Nov 20, 2001
Decision	Substantially Equivalent
Regulation	882.5970

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Source

View the full FDA submission: accessdata.fda.gov

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LERMAN & SON CRANIAL ORTHOSIS HELMET

Everything you need for a 510(k) submission. Nothing you don't.