FDA guidance

510(k) Checklist for Sterile Lubricating Jelly Used With Transurethral Surgical…

FDA guidance · Final · issued Sep 18, 1994

Key facts

Title 510(k) Checklist for Sterile Lubricating Jelly Used With Transurethral Surgical Instruments
Status Final
Issue date Sep 18, 1994
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

  • None Product codes referenced
  • None Recognized standards referenced

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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

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