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RE:RE:RE:RE:News not really

[Shoulton]

It shouldn't be more than 30 days (for now). Well let's hope so, else they may automatically have to resubmit completely.  

« Further, in accordance with 21 CFR 807.87(l), the Agency may consider a 510(k) to be 

withdrawn if additional information is not provided within 30 days following issuance of a 

request for additional information. In this instance, FDA may issue a notice of withdrawal.»

https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm089738.pdf