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Fda. gov/AbouitFDA/CentersOffices/CDRH/CDRHOffices/ucm II 5809. htm for the Center for Devices and Radiological Health s CDRH s Office of Compliance. Stephen Hx. Beier 3 11I Enterprise Drive Plainsboro New Jersey 08536 December 21 2012 Re K123000 Trade/Device Name INTEGRA Total Foot System Regulation Number 21 CFR 888. 510 k Number K10002 Trade Name Ascensiono Total Plate RS HWC RS HWCSystem Manufacturer Corporation formally Ascension Orthopedics Inc. K091614 Osetomed Foot Plating System...

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