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Device Evaluation Information

Forms

510(k)
	Indications for Use Form
	Status Request Form
	Submission Cover Sheet
	Screening Checklist
	Truthful and Accurate Statement
	Certification: Financial Interest & Arrangements of Clinical Investigators Form
	Financial Interst Form - Clinical Investigators
HDE
	Checklist for Filing Decision
	Certification: Financial Interest & Arrangements of Clinical Investigators Form
	Financial Interst Form - Clinical Investigators
PMA
	Checklist for Filing Decisions
	Review Statistical Checklist
	Realtime PMA Supplement
	Certification:: Financial Interest & Arrangements of Clinical Investigators Form
	Financial Interest Form - Clinical Investigators

Updated May 3, 2007

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Center for Devices and Radiological Health / CDRH

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