# Metal Expandable Biliary Stents - Premarket Notification (510(k)) Submissions:  Guidance for Industry and Food and Drug Administration Staff - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/metal-expandable-biliary-stents-premarket-notification-510k-submissions-guidance-for-industry-and-food-and-drug-administration-staff/f2e2118b-f14f-4d6e-a1e0-477e6c113acc

> FDA guidance document: Metal Expandable Biliary Stents - Premarket Notification (510(k)) Submissions:  Guidance for Industry and Food and Drug Administration Staff. Issue date: July 26, 2019. Get complete insights and analysis.

---

## Details

- Title: Metal Expandable Biliary Stents - Premarket Notification (510(k)) Submissions:  Guidance for Industry and Food and Drug Administration Staff
- Communication Type: Guidance Document
- Product Type: devices
- Office Name: Center for Devices and Radiological Health
- Office URL: /offices/center-for-devices-and-radiological-health/9d89aff6-e435-4764-87be-f58c01aca7f7
- Issue Date: 2019-07-26
- Last Changed: 2024-08-10
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2018-D-1771">FDA-2018-D-1771</a>

## Related Documents

- [Hydrogen Peroxide-Based Contact Lens Care Products: Consumer Labeling Recommendations - Premarket Notification (510(k)) Submissions:  Guidance for Industry and Food and Drug Administration Staff](https://www.globalkeysolutions.net/guidances/guidance-document/hydrogen-peroxide-based-contact-lens-care-products-consumer-labeling-recommendations-premarket-notification-510k-submissions-guidance-for-industry-and-food-and-drug-administration-staff/bad59cb4-dd60-41ee-ba97-c787dd647457)
- [Mouse Embryo Assay for Assisted Reproduction Technology Devices](https://www.globalkeysolutions.net/guidances/guidance-document/mouse-embryo-assay-for-assisted-reproduction-technology-devices/a9abbbb9-85c6-4354-bc6a-3f37a329e826)
- [Utilizing Animal Studies to Evaluate Organ Preservation Devices:  Guidance for Industry and Food and Drug Administration Staff](https://www.globalkeysolutions.net/guidances/guidance-document/utilizing-animal-studies-to-evaluate-organ-preservation-devices-guidance-for-industry-and-food-and-drug-administration-staff/e6f23ae2-2fa0-40d6-9abc-233e2ec8e4f6)
