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9 https://www.fda.gov/Regulatory-information/search-fda-guidance-documents/general-considerations-considerations-animal- Animal- animal- structed-tedended-evaluye-Medical-devices 10参见21 CFR 807.87和FDA指导文档指导文档“用于Medical Departing for Medical Depactions 510”（K） https://www.fda.gov/regulatory-information/search-fda-guidance- documents/electronic-submission-template-medical-device-510k-submissions 11 The scope of this guidance includes human demineralized bone matrix (DBM) that is more than minimally manipulated or modified with additives (except for sterilizing, preserving, or storage agents).有关更多信息，请参见2001年1月19日（66 FR 5447）的联邦公报通知和FDA网页，“司法管辖区更新：人类脱矿质骨基质”，可在https://www.fda.gov/combination-products/jurisdipation--jurisditial------------------------------
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