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U.S. Department of Health and Human Services

Product Classification
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Device seed, isotope, gold, titanium, platinum
Regulation Description Radionuclide brachytherapy source.
Regulation Medical Specialty Radiology
Review Panel Radiology
Product CodeIWG
Premarket Review Office of Radiological Health (OHT8)
Division of Radiological Imaging and Radiation Therapy Devices (DHT8C)
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? Yes
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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