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U.S. Department of Health and Human Services

Product Classification

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Device system, rebreathing, radionuclide
Regulation Description Radionuclide rebreathing system.
Regulation Medical Specialty Radiology
Review Panel Radiology
Product CodeIYT
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 892.1390
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review
Accredited Persons

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