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Get Chapter 17-fmh. Establishment Inspection Report, Berkshire Layers Egg Producer - Fda

NT SUMMARY The initial assessment should be completed within one week of being assigned a new Traditional 510(k) submission. Send completed forms to Frances Daniel (Frances.Daniel fda.hhs.gov), who is collecting data to evaluate the pilot Triage program. Quick Review Criteria 1. The division has review experience and knowledge of expected device performance 2. An extensive consult is not required 3. TPLC checklist does not raise new postmarket issues 4. Quick Review checklist only raises minor i.

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