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Home > Newsletters > Devices & Diagnostics Letter > Indianapolis Helmet Maker Warned on Records, Procedural Flaws

Devices & Diagnostics Letter

June 11, 2012 | Vol. 39 No. 24

Indianapolis Helmet Maker Warned on Records, Procedural Flaws

The FDA has cited a manufacturer of cranial remodeling helmets on seven areas of documentation and policy flaws.

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