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When I submit a 510(k) eSubmission for OIVD using the CeSub eSubmitter software, do I need to include hardcopies of the 510(k)?

CeSub esubmission esubmitter hardcopies OIVD Software submit
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When I submit a 510(k) eSubmission for OIVD using the CeSub eSubmitter software, do I need to include hardcopies of the 510(k)?

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No, you only need to submit the CD (eSubmission) and a signed Submittal Letter generated from the CeSub eSubmitter software.

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