FDA guidance
Guidance for the Content of Premarket Notifications (510(k)s) for Extracorporeal Shock…
FDA guidance · issued Aug 8, 2000
Key facts
| Title | Guidance for the Content of Premarket Notifications (510(k)s) for Extracorporeal Shock Wave Lithotripters Indicated for the Fragmentation of Kidney and Ureteral Calculi - Guidance for Industry and for FDA Reviewers |
|---|---|
| Issue date | Aug 8, 2000 |
At a glance
- 1–9 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