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Re: Seeking copy of Letter from M. Lang FDA, DOC Not Investigational

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This may not be exactly what you are looking for, but look at this and see if it helps if you haven't seen these already.

http://www.cranialtech.com/regulatoryinfo.html

This might be another helpful resource: http://cpcj.allenpress.com/cpcjonline/?request=get-document & doi=10.1597%2F1545-1569(2001)038%3C0337:FADARO%3E2.0.CO%3B2

You might find more here: http://www.cranialtech.com/parentsarea/publications/ref1.pdf

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