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U.S. Department of Health and Human Services

Product Classification

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Device needle, isotope, reprocessed
Regulation Description Radionuclide brachytherapy source.
Regulation Medical Specialty Radiology
Review Panel Radiology
Product CodeNMP
Premarket Review Division of Radiological Health (DRH)
Division of Radiological Health (DRH)
Submission Type 510(k)
Regulation Number 892.5730
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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