Important Notice For U. The sale of this item may be subject to regulation by the U. Food & Drug Administration and state and local regulatory agencies. If you have questions about legal obligations regarding sales of medical devices, you should consult with the FDA’s Center for Devices and Radiological Health. 510(K) Number: K181691. Regulation Number: 872.4200. Classification Product Code: EFB. Subsequent Product Code: EGS.
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