Exam (elaborations)
RAC Device General Exam Prep Graded A+
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A 510k is Approved or Cleared? - ANSWER-Cleared A type of 510(k) submission for device modifications neither affecting the intended use nor altering its fundamental scientific technology. FDA processing time is 30 days. - ANSWER-Special 510(k) A type of 510(k) submission that is supported by ...
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