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The top documents tagged [predicate device]
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Corrosion Testing for Medical Device Validation. Effect of Corrosion on the Body Compatibility Tissue response Leach rates Toxicity
218 views
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Our Designer Future: How FDA Legal Issues Shape Human Health– From Medical Devices to Mobile Apps SoCal IP December 4, 2013 Michael H. Cohen, JD, MBA Michael
217 views
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Valved Holding Chambers V1
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Health & Medicine
Plenary melissa thompson
1.052 views
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Toxicological Testing for Devices Versus Drugs & Biologics
475 views
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"Determining the Regulatory Pathway to Market" Classification Heather S. Rosecrans Director, 510(k) Staff Office of Device Evaluation Center for Devices
219 views
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Slide 1 of 19 Rob Packard, President
[email protected]
216 views
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510(k) Submissions Recent Experience and Perspectives Terry Sullivan Vice President, Regulatory Affairs
218 views
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510(k) Submissions Recent Experience and Perspectives
30 views
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FDA 510K Clearance Certification K021526 Tri-Cyclic Anti-Depressants (TCA) Drug Testing Kits
218 views
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FDA 510K Clearance Certification K041822 Amphetamine (AMP) 300 Drug Testing Kits
227 views
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FDA 510K Clearance Certification K022589 Ecstasy (MDMA) Drug Screening Kits
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