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並前往https://www.fda.gov/medical-devices/guidance-documents-medical-devices-and-radiation-emitting-products/cardiopulmonary-bypass-arterial-line-blood-filter-510k-submissions-final-guidance-industry-and-fda

Cardiopulmonary Bypass Arterial Line Blood Filter 510(k ...

Describes a means by which cardiopulmonary bypass arterial line blood filter devices may comply with the requirement of special controls for ...

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