# Determination of Intended Use for 510(k) Devices - Guidance for CDRH Staff (Update to K98-1) - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/determination-of-intended-use-for-510k-devices-guidance-for-cdrh-staff-update-to-k98-1/5bf830b5-ab1f-45b6-ba8f-b8c4628d709d

> FDA guidance document: Determination of Intended Use for 510(k) Devices - Guidance for CDRH Staff (Update to K98-1). Issue date: December 02, 2002. Get complete insights and analysis.

---

## Details

- Title: Determination of Intended Use for 510(k) Devices - Guidance for CDRH Staff (Update to K98-1)
- 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: 2002-12-02
- Last Changed: 2020-03-19
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2020-D-0957">FDA-2020-D-0957</a>

## Related Documents

- [Guidance Document for Dura Substitute Devices - Guidance for Industry](https://www.globalkeysolutions.net/guidances/guidance-document/guidance-document-for-dura-substitute-devices-guidance-for-industry/e1d5a8ce-a400-4b78-9fc5-d3147a989074)
- [Information for Keratome Manufacturers Regarding LASIK - Final Guidance for Industry](https://www.globalkeysolutions.net/guidances/guidance-document/information-for-keratome-manufacturers-regarding-lasik-final-guidance-for-industry/e5b189cc-d972-4a93-8dc5-b39ad36a40e3)
- [Pediatric Expertise for Advisory Panels - Guidance for Industry and FDA Staff](https://www.globalkeysolutions.net/guidances/guidance-document/pediatric-expertise-for-advisory-panels-guidance-for-industry-and-fda-staff/64e434d8-3d9c-45cc-ae8a-11155709b0a9)