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U.S. Department of Health and Human Services

Product Classification

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Device filter, prebypass, cardiopulmonary bypass
Regulation Description Cardiopulmonary prebypass filter.
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeKRJ
Premarket Review Office of Device Evaluation (ODE)
Division of Cardiovascular Devices (DCD)
Circulatory Support Devices Branch (CSDB)
Submission Type 510(k)
Regulation Number 870.4280
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review
Accredited Persons

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