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Reprocessing of Single-Use Devices
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Reprocessing of Single-Use Devices

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Statement of Daniel Schultz, M.D., Director CDRH, Before the Committee on Government Reform - September 26, 2006

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List of Device Types Previously Exempt From Premarket Notification (510(k)) Requirements That Now Require 510(k)s With Validation Data (List 1)

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* List of Reprocessed Single-Use Devices Subject to Premarket Notification (510(k)) Requirements That Now Require the Submission of Validation Data Text
* List of Single-Use Devices Known To Be Reprocessed or Considered for Reprocessing (Attachment 1) Text
* Definitions Text
* Reprocessed Single-Use Device Timeline Text
* Search FDA’s Web Site for Cleared Reprocessed Single-Use Devices Text

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Updated September 26, 2006

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