510(k)
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Indications for Use Form |
![Text](https://webarchive.library.unt.edu/eot2008/20081023150139im_/http://www.fda.gov/cdrh/images/linker1.gif) |
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Status Request Form |
![Text](https://webarchive.library.unt.edu/eot2008/20081023150139im_/http://www.fda.gov/cdrh/images/linker1.gif) |
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Submission Cover Sheet |
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![PDF](https://webarchive.library.unt.edu/eot2008/20081023150139im_/http://www.fda.gov/cdrh/images/linker2.gif) |
![WORD](https://webarchive.library.unt.edu/eot2008/20081023150139im_/http://www.fda.gov/cdrh/images/linker4.gif) |
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Screening Checklist |
![Text](https://webarchive.library.unt.edu/eot2008/20081023150139im_/http://www.fda.gov/cdrh/images/linker1.gif) |
![PDF](https://webarchive.library.unt.edu/eot2008/20081023150139im_/http://www.fda.gov/cdrh/images/linker2.gif) |
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Truthful and Accurate Statement |
![Text](https://webarchive.library.unt.edu/eot2008/20081023150139im_/http://www.fda.gov/cdrh/images/linker1.gif) |
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Certification: Financial Interest & Arrangements of Clinical Investigators
Form |
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![PDF](https://webarchive.library.unt.edu/eot2008/20081023150139im_/http://www.fda.gov/cdrh/images/linker2.gif) |
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Financial Interst Form - Clinical Investigators |
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![PDF](https://webarchive.library.unt.edu/eot2008/20081023150139im_/http://www.fda.gov/cdrh/images/linker2.gif) |
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HDE
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Checklist for Filing Decision |
![Text](https://webarchive.library.unt.edu/eot2008/20081023150139im_/http://www.fda.gov/cdrh/images/linker1.gif) |
![PDF](https://webarchive.library.unt.edu/eot2008/20081023150139im_/http://www.fda.gov/cdrh/images/linker2.gif) |
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Certification: Financial Interest & Arrangements of Clinical Investigators
Form |
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![PDF](https://webarchive.library.unt.edu/eot2008/20081023150139im_/http://www.fda.gov/cdrh/images/linker2.gif) |
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Financial Interst Form - Clinical Investigators |
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![PDF](https://webarchive.library.unt.edu/eot2008/20081023150139im_/http://www.fda.gov/cdrh/images/linker2.gif) |
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PMA
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Checklist for Filing Decisions |
![Text](https://webarchive.library.unt.edu/eot2008/20081023150139im_/http://www.fda.gov/cdrh/images/linker1.gif) |
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Review Statistical Checklist |
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![PDF](https://webarchive.library.unt.edu/eot2008/20081023150139im_/http://www.fda.gov/cdrh/images/linker2.gif) |
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Realtime PMA Supplement |
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![PDF](https://webarchive.library.unt.edu/eot2008/20081023150139im_/http://www.fda.gov/cdrh/images/linker2.gif) |
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Certification:: Financial Interest & Arrangements of Clinical Investigators
Form |
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![PDF](https://webarchive.library.unt.edu/eot2008/20081023150139im_/http://www.fda.gov/cdrh/images/linker2.gif) |
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Financial Interest Form - Clinical Investigators |
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![PDF](https://webarchive.library.unt.edu/eot2008/20081023150139im_/http://www.fda.gov/cdrh/images/linker2.gif) |
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