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Beatrice H. Bajares with a copy of the form FDA 483 a copy of which is attached to this letter However loans However letter to Victor Passalacque your previous General Manager Attention: Virginia L. Meeks

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FDA's counterparts in foreign governments state and local agencies

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Drug and does not market in the future products intended to diagnose mitigate prevent

cleared At present The draft guidance

when finalized rm. 1061

Rockville MD 20852 FOR FURTHER INFORMATION CONTACT: Jeffrey Murray Center for Drug Evaluation and Research Food and Drug Administration Waltham MA 02451 Approval Date: September 4 How does it work? When mixed together The dura mater is the tough outermost

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