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並前往https://www.govinfo.gov/app/details/CFR-2013-title21-vol8/CFR-2013-title21-vol8-sec807-90

21 CFR 807.90 - Format of a premarket notification submission.

Part 807 - ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR MANUFACTURERS AND INITIAL IMPORTERS OF DEVICES Subpart E - Premarket Notification Procedures

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