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Web section c of cdrh premarket review submission cover sheet (form fda 3514) or in section b (if section c is blank on the cover sheet form), or in the cover. Web form fda 3514, a summary cover sheet form, assists respondents in categorizing administrative 510(k) information for submission to fda. Web form fda 3514 (1/13) pma pma & hde supplement establishment registration number (if known) original submission pdp 510(k) humanitarian device other submission. There are 22 slides in this presentation, and the.
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