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Re: uksausage post# 55882

Friday, 10/09/2015 10:06:26 AM

Friday, October 09, 2015 10:06:26 AM

Post# of 330241
"To date, FDA has not cleared an SWT device for OTC use
and, as a result, has limited the reclassification in this final order to prescription use devices.
However, if FDA receives a marketing application in the future for an SWT device indicated for
OTC use, FDA would make its classification decision regarding such use at that time."
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