FDA guidance
Addendum to: Guidance on Premarket Notification [510(k)] Submissions for Sterilizers…
FDA guidance · Final · issued Sep 18, 1995
Key facts
| Title | Addendum to: Guidance on Premarket Notification [510(k)] Submissions for Sterilizers Intended for Use in Health Care Facilities |
|---|---|
| Status | Final |
| Issue date | Sep 18, 1995 |
| Center | Center for Devices and Radiological Health |
| Issuing office | Center for Devices and Radiological Health |
| Communication type | Guidance Document |
| Regulated product | Medical Devices |
| Topics | Premarket |
| Docket number | FDA-2020-D-0957 |
| Open for comment | No |
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