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Duke2484

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Duke2484

Re: Presto101 post# 115442

Tuesday, 11/07/2017 10:54:18 AM

Tuesday, November 07, 2017 10:54:18 AM

Post# of 330178
You could not be more wrong. There is a decision tree that needs to be reviewed as part of the submission. If you run through it there is a good chance they will need to submit a new 510(k). Changing labeling and indications for use almost always trigger it.

If you don’t believe me google 510k decision tree.
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