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De Novo Submission – DEN200080 (Pre-Submission Communications)
De Novo Submission – DEN200080 (Pre-Submission Communications)
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Request Contents: DEN200080 submitted to the FDA, and associated subsequent FDA questions and manufacturer's response -Pre-submission applications, meeting minutes, written FDA feedbacks which precedes the de novo clearance of DEN200080.
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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