FDA guidance
Third Party Review Guidance for Phacofragmentation System Device Premarket Notification…
FDA guidance · Final · issued Jan 31, 1997
Key facts
| Title | Third Party Review Guidance for Phacofragmentation System Device Premarket Notification (510(k)) |
|---|---|
| Status | Final |
| Issue date | Jan 31, 1997 |
| Center | Center for Devices and Radiological Health |
| Issuing office | Center for Devices and Radiological Health |
| Communication type | Guidance Document |
| Regulated product | Medical Devices |
| Docket number | FDA-2020-D-0957 |
| Open for comment | No |
| Document on fda.gov | fda.gov |
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