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Import and Export Regulations for Medical Device | Fish The export of an eligible device is permitted to Tier 1 countries and other countries that accept Tier 1 authorization if the device meets the four export criteria of Section 801(e)(1) for 510(k)-able devices listed above and (i) is not adulterated, (ii) is not the subject of an “imminent hazard” notice issued by the U.S. government, (iii .

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Product Classification - Food and Drug Administration TPLC Product Code Report. Summary Malfunction. Recognized Consensus Standards. 6-254 ASTM F2100-11 (Reapproved 2018) Standard Specification for Performance of Materials Used in Medical Face Masks. 6-335 ASTM F2101-14. Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological .

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