FDA guidance
Latex Condoms for Men - Information for 510(k) Premarket Notifications: Use of Consensus…
FDA guidance · Final · issued Jul 23, 1998
Key facts
| Title | Latex Condoms for Men - Information for 510(k) Premarket Notifications: Use of Consensus Standards for Abbreviated Submissions: Guidance for Industry |
|---|---|
| Status | Final |
| Issue date | Jul 23, 1998 |
| 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 |
| 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