FDA guidance

Guidance for Cardiopulmonary Bypass Oxygenators 510(k) Submissions - Final Guidance for…

FDA guidance · issued Nov 12, 2000

Key facts

Title Guidance for Cardiopulmonary Bypass Oxygenators 510(k) Submissions - Final Guidance for Industry and FDA Staff
Issue date Nov 12, 2000

At a glance

  • 10–99 Product codes referenced
  • 1–9 Recognized standards referenced

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA guidance documents

FDA guidance documents describe the agency's current thinking on regulatory topics. Drafts are issued for comment before a final version is published.

Source: U.S. Food and Drug Administration (FDA), Guidance Documents

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