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U.S. Department of Health and Human Services

Product Classification

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Device source, isotope, sealed, gold, titanium, platinum
Regulation Description Radionuclide brachytherapy source.
Regulation Medical Specialty Radiology
Review Panel Radiology
Product CodeIWI
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 892.5730
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons