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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. Phone Fax 1-631-584-6688 Contact Email Jimmy Wu 1-513-693-3697 jwu leexiao. com Date Submitted 2/5/2016 Device Device Name Common Name CFR Section Product Classification Classification Panel LT-300 HD Colposcope HEX 21 CFR 884. ISO 8600-5 2005 Optics and photonics-Medical endoscopes and endotherapy devices part 5...
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