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U.S. Department of Health and Human Services

Product Classification
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Device apparatus, hemoperfusion, sorbent
Regulation Description Sorbent hemoperfusion system.
Regulation Medical Specialty Gastroenterology/Urology
Review Panel Gastroenterology/Urology
Product CodeFLD
Submission Type 510(k)
Regulation Number 876.5870
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
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