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Re: Freeblazer post# 78815

Thursday, 06/09/2016 9:35:49 AM

Thursday, June 09, 2016 9:35:49 AM

Post# of 330600
On June 8, an FDA representative notified company counsel that the agency believes that the 510(k) pathway may be available for the ActiPatch device, the agency staff is reviewing the company’s data, and the agency would be back to the company shortly with its pathway determination and advice regarding whether additional information is necessary.
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