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U.S. Department of Health and Human Services

Product Classification
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Device bone marrow processing device to support hematopoietic reconstitution
Regulation Description Automated blood cell separator.
Definition Processing of bone marrow harvested from human donors to support hematopoietic reconstitution in a recipient.
Physical State May include centrifuge, pumps, valves, computerized safety/control systems, sterile single-use disposable tubing, and bags
Technical Method Relies on a centrifugal field and may include filtration methods for separation of harvested bone marrow into its cellular and non-cellular components.
Target Area Bone marrow aspirates obtained from the iliac crest of human donors, processed and infused into the recipient¿s circulatory system
Regulation Medical Specialty Hematology
Review Panel Hematology
Product CodePKG
Premarket Review Center for Biologics Evaluation & Research (CBER)
Submission Type 510(k)
Regulation Number 864.9245
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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