mdcpp.com - /doc/doctemp/FDA 无源非无菌产品传统510k 递交模板/

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 2025/2/15    11:51         1355 360手机助手.lnk
  2024/4/9    11:04        21029 FT001-0.0_Preface.docx
  2024/4/9    11:04        27477 FT001-1.0_Table of Contents.docx
  2024/4/9    11:04        21097 FT001-10.1_Financial Certification or Disclosure Statement.docx
  2024/4/9    11:04        21166 FT001-10.2-0_Financial Certification and Financial Disclosures.docx
  2024/4/9    11:04       730640 FT001-10.2-1_Financial Certification.pdf
  2024/4/9    11:04        21936 FT001-10.2-2_Financial Disclosures.docx
  2024/4/9    11:04       897926 FT001-10.3-1_FDA_3454 Financial Certification.pdf
  2024/4/9    11:04       898044 FT001-10.3-2_FDA_3455 Financial Disclosures.pdf
  2024/4/9    11:04        21178 FT001-11.1_Declarations of Conformity and Summary Reports.docx
  2024/4/9    11:04        28061 FT001-12.0_Device Description.docx
  2024/4/9    11:04        30868 FT001-13.0_Executive Summary Predicate Comparison.docx
  2024/4/9    11:04        27045 FT001-14.0_Substantial Equivalence Discussion.docx
  2024/4/9    11:04        21141 FT001-15.0_Proposed Labeling.docx
  2024/4/9    11:04       159778 FT001-15.1_Package Label.docx
  2024/4/9    11:04       169526 FT001-15.2_Product label.docx
  2024/4/9    11:04        21880 FT001-16.0_Sterilization and Shelf Life.docx
  2024/4/9    11:04        53728 FT001-16.1_Age testing report.docx
  2024/4/9    11:04        28388 FT001-17.0_Biocompatibility.docx
  2024/4/9    11:04        21254 FT001-18.0_Software.docx
  2024/4/9    11:04        25839 FT001-19.0_Performance Testing_Bench.docx
  2024/4/9    11:04       131076 FT001-2.0_Refuse to Accept for 510k_Acceptance Checklist for Traditional 510(k)s.docx
  2024/4/9    11:04        21209 FT001-20.0_Electromagnetic Compatibility and Electrical Safety.docx
  2024/4/9    11:04        21223 FT001-21.0_Specific product Test Report.docx
  2024/4/9    11:04        20894 FT001-22.0_ISO 10993-5 Test Report.docx
  2024/4/9    11:04        20972 FT001-23.0_ISO 10993-10 Test Report.docx
  2024/4/9    11:04        21036 FT001-24.0_Performance Testing – Animal.docx
  2024/4/9    11:04        21653 FT001-25.0_Performance Testing – Clinical.docx
  2024/4/9    11:04        21134 FT001-3.1_Medical Device User Fee Cover Sheet (Form FDA 3601).docx
  2024/4/9    11:04       275831 FT001-3.2_Medical Device User Fee Cover Sheet (Form FDA 3601).pdf
 2025/2/15    11:50        13317 FT001-4.1_FDA-3514 Cover Sheet.docx
 2025/2/15    11:51      4163251 FT001-4.2_FDA-3514 Cover Sheet.pdf
  2024/4/9    11:04        33155 FT001-5.0_510(k) Cover Letter.docx
  2024/4/9    11:04        20586 FT001-6.1_Indications for Use Statement (FDA Form 3881).docx
  2024/4/9    11:04       220656 FT001-6.2_Indications for Use Statement (FDA Form 3881).pdf
  2024/4/9    11:04        31823 FT001-7.0_510(k) Summary.docx
  2024/4/9    11:04        21324 FT001-8.0_Class III Summary and Certification.docx
  2024/4/9    11:04        21902 FT001-9.0_Truthful and Accuracy Statement.docx
 2025/2/15    11:50         1080 Internet Download Manager.lnk
 2025/2/15    11:51         1226 WPS Office.lnk
 2025/2/15    11:51        <dir> 共享