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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. Eydelman M. D. Director Division of Ophthalmic and Ear Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure Form Approved OMB No. 0910-0120 Expiration Date January 31 2017 Indications for Use See PRA Statement on last page. 510 k Number if known Device Name ALADDIN HW3. 0...
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It is a medical imaging system used for skin analysis.
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Patient demographics, skin type, and specific skin concerns must be reported on visia imaging s.
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