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Re: JTORENCE post# 45048

Wednesday, 06/21/2017 6:36:33 PM

Wednesday, June 21, 2017 6:36:33 PM

Post# of 52074
FDA will respond to the entity that submits the 513(g) within 60 days---there is no site to check decisions

see III B here:

https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm209851.pdf

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