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Fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also please note the regulation entitled Misbranding by reference to premarket notification 21 CFR Part 807. 6HPLK 2NWD President CardioMed Device Consultants LLC 5523 Research Park Drive Suite 360 Baltimore Maryland 21228 Re K150487 Trade/Device Name X-Suit NIR Biliary Metallic Stent Regulation Number 21 CFR 876. Type of Use Select one or both as applicable Prescription Use Part 21 CFR 801 Subpart D Over-The-Counter Use 21 CFR 801...
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Cardiomed Device Consultants LLC is a consulting company that specializes in medical devices.
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