FDA 510(k) Pre-Market Application K191402 – Includes all associated agency communications, Class 2 recall Z-1498-2020, and requests for additional information.

FDA 510(k) Pre-Market Application K191402 – Includes all associated agency communications, Class 2 recall Z-1498-2020, and requests for additional information.

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Original Request: 510(k) pre-market application k191402 and all associated agency communications including requests for additional information and informal emails if applicable. Agency communication regarding class 2 recall Z-1498-2020
  • 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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