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510(K) Document Experts| The following experts are available as 510(k) document consultants and 510(k) document expert witnesses. Intota experts are peer-recommended authorities who have been carefully selected and rigorously screened. |  | | | Definition: 510(K) Document -
The official document that is submitted to the Food and Drug Administration when seeking premarket approval for a medical device that is not life-supporting, implanted, or otherwise considered critical in sustaining life, such as a syringe or cloth bandage. (Synonyms: 510k, medical device premarket notification) |
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 | Experts 1 to 25 of 54 |  | 510(K) Document Experts |  | Request Free Expert Quote |  |  | Expert 723272 |  | Expert in Parasitology, Immunology, Microbiology, Bioterror Agents, Grant Writing, Med Writing, Expert Witness |  |  |  |  |  | Expert 725237 |  | Expert in Medical Device Design and Development |  |  |  |  |  | Expert 713595 |  | Expert in FDA Consultation for Medical Devices, Cosmetics, and Drugs |  |  |  |  |  | Expert 711196 |  | Expert in Intellectual Property |  |  |  |  |  | Expert 721781 |  | Expert in Biomaterials and Product Development R&D for Orthopedic, Cardiovascular, and Other Implants |  |  |  |  |  | Expert 722432 |  | Expert in Biotechnology Product Reviews, Biologics, Drugs & Medical Devices, FDA Litigation, Vaccines, etc. |  |  |  |  |  | Expert 722724 |  | Expert in EMC/EMI, RF/Microwave, Hardware, Firmware, Product Development |  |  |  |  |  | Expert 723204 |  | Expert in Biomedical Engineering; Medical Devices; Expert Reports for Legal Services; Industry Consulting |  |  |  |  |  | Expert 724385 |  | Expert in Sutures, Medical Devices, Moisture Degradation, Absorbable Polymers, Implant Devices |  |  |  |  |  | Expert 725158 |  | Expert in Medical Devices, In Vitro Diagnostics Design, Quality Control, Trouble-Shooting, etc. |  |  |  |  |  | Expert 725331 |  | Expert in Medical Device Regulatory Submissions |  |  |  |  |  | Expert 726193 |  | Expert in Medical Device Design and Analysis |  |  |  |  |  | Expert 726245 |  | Expert in Implantable and Non-Implantable Medical Device Risk, Safety, and Failures |  |  |  |  |  | Expert 107726 |  | Expert in Medical Device, Biotech, Pharma R&D, Tech Transfer, Mfg, Compliance, IP Valuation, Process Improvement |  |  |  |  |  | Expert 713381 |  | Expert in Medical Technology |  |  |  |  |  | Expert 711960 |  | Expert in Wound Care Technical Product Development and Commercialization |  |  |  |  |  | Expert 714180 |  | Expert in Telemedicine Configuration Testing and PACS Devices, Software QA, FDA Warning Letters, etc. |  |  |  |  |  | Expert 714290 |  | Expert in Latex Dipping |  |  |  |  |  | Expert 717319 |  | Expert in Medical Device Design and Manufacturing: Laboratory Devices, Surgical Instruments, and Disposables |  |  |  |  |  | Expert 721893 |  | Expert in Oxygen Therapy & Conservation, Biofeedback, Clinical Management Design, Electronics, & Prototyping |  |  |  |  |  | Expert 722568 |  | Expert in Practical Application of GLP, GCP, and cGMP to Pharmaceutical, Device, and Biotechnology Firms |  |  |  |  |  | Expert 722786 |  | Expert in Healthcare Consulting: Strategic Planning, Product Development, and Product Launch |  |  |  |  |  | Expert 722935 |  | Expert in Medical Device Design and Manufacturing, Measurement Systems, Embedded Systems, etc. |  |  |  |  |  | Expert 723111 |  | Expert in Litigation - Expert Witness on Pharmaceutical Matters (FDA Compliance) |  |  |  |  |  | Expert 723158 |  | Expert in Medical Device: Design, Development, Manufacturing and Quality Assurance |  |  |  |  |  |  | >> Next 25 Experts
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