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Medical X-Ray Imaging Devices Conformance with IEC Standards
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Consumer Information on: PD-L1 IHC 28-8 pharmDx
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Consumer Information on: Axium Neurostimulator System
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Consumer Information on: Blazer Open-Irrigated Ablation Catheter
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Consumer Information on: Integra Omnigraft Dermal Regeneration Matrix – Interactive Wound Dressing
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Consumer Information on: Sorin Perceval Sutureless Heart Valve
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Consumer Information on: Storz Medical Duolith SD1 Shock Wave Therapy Device
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FY 2017 Medical Device User Fee Small Business Qualification and Certification
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Letter: Important Information on Medical Device User Fees for Fiscal Year 2017 (October 1, 2016 through September 30, 2017)
August 1, 2016 Dear Medical Device Establishment: This letter provides information regarding medical device user fees, including fee rates and payment procedures, for Fiscal Year 2017 (FY17), which runs from October 1, 2016 through September 30, 2017. Federal Law (Food and Drug Administration Safety and Innovation Act – FDASIA) authorizes the U.S. Food and Drug…