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U.S. Department of Health and Human Services

Product Classification

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Device apparatus, suction, patient care
Regulation Description Patient care suction apparatus.
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeDWM
Premarket Review Office of Device Evaluation (ODE)
Division of Cardiovascular Devices (DCD)
Circulatory Support Devices Branch (CSDB)
Submission Type 510(k)
Regulation Number 870.5050
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons