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Summary.pdf

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🔗 Source: accessdata.fda.gov
📊 Size: 1.1 MB
📄 Pages: 7 pages
⬇️ Downloads: 36

Summary

The U.S. Food & Drug Administration (FDA) has determined that Fiagon GmbH's FlexPointer 1.5 Single Use and FlexTube 3 Single Use devices are substantially equivalent to legally marketed predicate devices, and thus may be marketed, subject to general controls provisions of the Federal Food, Drug, and Cosmetic Act. The devices are classified as Class II and are intended for use in ENT procedures as an aid for precisely locating anatomical structures.

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The U.S.

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  • File Format: PDF
  • File Size: 1.1 MB
  • Pages: 7
  • Language: EN
  • Total Downloads: 36
  • Last Updated: 1 month ago

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