# The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]:  Guidance for Industry and Food and Drug Administration Staff - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/the-510k-program-evaluating-substantial-equivalence-in-premarket-notifications-510k-guidance-for-industry-and-food-and-drug-administration-staff/b5031711-1d58-4c45-b081-f570f50bba71

> FDA guidance document: The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]:  Guidance for Industry and Food and Drug Administration Staff. Issue date: July 28, 2014. Get complete insights and analysis.

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## Details

- Title: The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]:  Guidance for Industry and Food and Drug Administration Staff
- Communication Type: Guidance Document
- Product Type: devices
- Office Name: Center for Devices and Radiological Health
- Office URL: /offices/center-for-devices-and-radiological-health/9d89aff6-e435-4764-87be-f58c01aca7f7
- Issue Date: 2014-07-28
- Last Changed: 2019-03-28
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2011-D-0652">FDA-2011-D-0652</a>

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