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We are withdrawing this manual because the information is outdated. Please see the CDRH Device Advice page http://www.fda.gov/cdrh/devadvice/pma for updated information. For questions regarding this document, please contact Gene Allen at 301 443-6597 x114 or email dsmica@cdrh.fda.gov
Updated 8/13/2003
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Center for Devices and Radiological Health / CDRH