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Fda.gov/AboutFDA/CentersOfFices/CDRH/CDRHOffics/ucm II 5809. htm for the Center for Devices and Radiological Health s CDRI- s Office of Compliance. LLC 1394 2 5 hStreet. NW Buffalo. MN 553 13 Re K131401 Trade/Device Name BlowfishTM Transbronchial Micro-infusion Catheter Regulation Number 21 CFR 874. Comparison to Predicate Device The Blowfish Transbronchial Micro-Infusion Catheter is substantially equivalent to the predicate. Fda.gov/Medicaloevices/SafevyReportaProblem/default.htm for the...
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5 10k notification must include a company's financial statements, management's discussion and analysis, and other relevant information.
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